Funded Grants

Select a cancer type or topic below to view relevant research studies and information.

Breast Cancer Research

Trametes Versicolor in Breast Cancer Patients (G-04-006)
Leanna J. Standish, MD, Bastyr University, Kenmore, WA

The purpose of this project is to investigate the effects of a commonly prescribed herbal medicine used in immune therapy in women with breast cancer. This study will be the first U.S. trial to measure the safety and effectiveness of this orally administered immune cancer therapy for women with early breast cancer.

Potential Patient Impact: The impact on women will be information re the safety of an herbal medicine commonly used in cancer patients. It is possible that data from the study will show that this herb may have a role in treating post-radiation fatigue and immune deficiency in women with breast cancer.

A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer (G-04-050)
Augustin A. Garcia, MD, Cedars Sinai Research Institute, Los Angeles, CA

A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer (G-04-050)

Currently, the only ways to prevent breast cancer are prophylactic mastectomy or the use of tamoxifen, an anti-estrogen that has serious side effects. Dr. Garcia is studying whether dietary supplementation with omega-3 fatty acids, which come from fatty cold-water fish, could provide a less drastic option for preventing breast cancer.

Potential Patient Impact: This study focuses on prevention of breast cancer linked to diet and the impact it can have on women. It has the potential to provide a readily available dietary option for women to prevent breast cancer.

Prayer as a Possible Adjuvant Treatment for Cancer Patients (G-04-010). [Active Study]
Daniel Nixon, Southwestern Regional Medical Center, Tulsa, OK
[Funded through the Walter Payton Cancer Fund].

Research suggests a positive relationship between religiosity and reduced morbidity and mortality. The purpose of this pilot is to investigate specific biomarkers [biochemical and inflammatory/immune measurements] underlying the beneficial effects among breast cancer patients who pray.

Potential Patient Impact: Prayer, often believed a powerful mechanism in combating cancer, will be quantified and if proven scientifically effective, could have significant impact on the lives of cancer patients globally.

Longitudinal study of the effects of soy isoflavones and probiotics on indicators of breast cancer risk in healthy premenopausal women (G 01-000). *[Active Study]
Leonard Cohen/Peter Holt, Institute for Cancer Prevention, New York, NY

The goal of this study is to determine if dietary soy supplementation can affect biochemical parameters known to be associated with breast cancer.

Potential Patient Impact: Millions of premenopausal women supplement their diets with soy products in the hope of lowering their risk of breast cancer. This is a significant expense to the public yet the value of soy in this setting has never been confirmed in a research study. These investigators will evaluate the importance of soy to reduce breast cancer and provide valuable information to women regarding its use. If soy has value we will be able to add an important and inexpensive modality to the prevention of the most common cancer in American women and potentially save millions of lives.
[Funded through the Marcus Foundation, Inc.]

Targeted Killing of Breast Cancer Cells [G-02-022] [Active Study]
Timothy Fleming, Washington University, St. Louis, MO

The rationale for this project is to demonstrate the feasibility of a new therapeutic approach to specifically kill breast cancer cells.

Potential Patient Impact: This strategy relies on a gene that induces cell suicide” as the killing mechanism in breast cancer cells. This approach is unique as it “turns on” the killing gene thus eliminating any non-specific killing of normal, healthy cells in breast cancer patients.

Her-2/neu [HER2] Intracellular Domain Protein [ICD] Vaccines for the Prevention of Recurrences of HER-2 Overexpressing Breast Cancer and Ovarian Cancer (G-00-020). [Active Study]
Mary [Nora] Disis, University of Washington Seattle, WA

Despite advances in surgery, chemotherapy and radiation, patients with breast and ovarian cancer may relapse because of residual microscopic disease. It is now known that certain proteins made by a cell can cause malignant transformation. These proteins can be recognized and targeted by the immune system much like an infectious disease. This study is developing a vaccine to eradicate residual sub-clinical breast cancer.

Potential Patient Impact: Breast cancer remains the most common cancer to effect American women. New treatments are desperately needed. This vaccine, by creating long lasting resistance to the outgrowth of residual tumor cells, offers hope to the 40,000 American women and many more worldwide who will die of breast cancer this year.

HER-2/neu Peptide Vaccines in Patients with Breast and Ovarian Cancer (G-96-087). [2 tumor types]*
Mary [Nora] Disis, University of Washington, Seattle, WA

Patient Impact: This therapy represents an important advance in the treatment of breast and ovarian cancer. The results have been published in five articles in respected, peer-reviewed journals. Dr. Disis, the principal investigator has received the Distinguished Researcher Award from the National Cancer Institute.

Virus Targeted Therapy for Breast Cancer (G-96-001)
Douglas Faller, Boston University School of Medicine, Boston, MA

Patient Impact: The results of this study were considered promising enough to warrant FDA approval for further studies to treat this often-deadly disease.

Cervical Cancer Research

A Cervical Cancer Vaccine Using Dendritic Cells and HPV Lipopeptide (G-00-015). [Active Study]
Michael Steller, Tuffs-New England Medical Center, Boston, MA

Infection with the human papillomavirus (HPV) has been causally linked with the development of cervical cancer, which remains a leading cause of cancer-related death in developing countries and is dramatically rising in the US. This study will develop an effective therapeutic vaccine for patients with refractory, cervical cancer.

Patient Impact: Cervical cancer was once thought to be completely preventable with the use of the Pap smear. Unfortunately, this disease is on the rise and a more deadly form seems to be escaping the detection of the Pap smear. This vaccine represents new hope for the thousands who will be afflicted with this devastating disease. This study has closed due to actions of the FDA on vaccine therapies.

Colon Cancer Research

Estrogen, Calcium, and Vitamin D in Colon Cancer Prevention (G-02-008). [Active Study]
Peter Holt, Strang Cancer Prevention Center, New York, NY

Colon cancer is the second most common cause of cancer death in the United States. Primary prevention to eliminate or delay the onset of premalignant polyps and malignant tumors is the approach of the 21st century.

Potential Patient Impact: This treatment has the potential to save lives of those who would develop colo-rectal cancer by determining if estrogen provides a protective effect against tumor formation.

A Randomized Trial of Surgery Versus Endoscopic Stent for Palliation of Malignant Colon Obstruction [G-03-043] [Active Study]
Hans Gerdes, Memorial Sloan-Kettering Cancer Center, New York, NY

Large bowel obstruction is a common presentation among cancer patients and can be treated with colostomy or endoscopic insertion of an expandable metal stent. Both offer distinct advantages and disadvantages.

Potential Patient Impact: Bowel blockage can often be due to cancer particularly when it occurs in the large bowel. This study will examine two common treatments for bowel blockage and explore the patient’s bowel symptoms and quality of life after surgery or stent treatment to determine the best outcome.

Inhibition of Colon Tumors in Human Populations (G96-006)
Martin Lipkin, Rockefeller University, New York, NY

Patient Impact: This clinical trial tested curcumin for the first time in human subjects to evaluate properties leading to tumor inhibition. The results may eventually lead to a safe, effective, widespread approach to inhibiting colonic tumors in human populations. CTRF was the first to fund this novel approach that is now being evaluated in numerous cancer studies around the country.

Leukemia / Lymphoma Research

Phase I/II Study of Noscapine for Patients with Low Grade Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy (G-00-011). [Active Study]
Dan Douer, University of Southern California, Los Angeles, CA

Noscapine is a cough suppressant used widely throughout Europe. At higher doses, it has been shown to have anti-cancer activity in laboratory animals. Mice who were injected with human tumors had a significant shrinkage of their cancer after treatment with noscapine. Several anecdotal cases already exist of patients who have failed multiple standard chemotherapy agents and have responded to noscapine. At least one of the patients remains free of disease several years after taking noscapine.

Potential Patient Impact: Non-Hodgkin’s lymphoma remains a difficult disease to cure; current treatments are highly toxic. Noscapine is a well-tolerated drug that may offer great potential for cure in patients who would otherwise die.

Cancer Immunotherapy with Allogenic Blood Lymphocytes (G-97-016).
Shimon Slavin, Hadassah University Hospital, Jerusalem, Israel

Patient Impact: A seven-year-old boy who had exhausted all other treatment options was brought to Dr. Slavin almost dead and is alive 20 years later due to his innovative treatment.

Cellular Immunotherapy in the Treatment of Lymphomas in Organ Transplant Recipients (G-96-025).
Abdul Rao, University of Pittsburgh Cancer Institute, Pittsburgh, PA

Patient Impact: Their ability to partially or completely treat refractory PTLD in 50% of evaluable patients underscored the impressive potential of autologous LAK cell therapy as a treatment of choice for organ transplant-related lymphoma. The lack of any associated toxicity also highlighted the safety of this procedure.

Lung Cancer Research

A Multi-Center Randomized Trial Evaluating the Chronotherapeutic Role of Melatonin in the Treatment of Stage III and IV Non-Small Cell Lung Carcinoma (G-00-017). [Active Study]
Chris Lis, Midwestern Regional Medical Center, Zion, IL

For most cancer patients, the cellular aging process limits the therapeutic benefits of cancer treatment by inhibiting the cell’s capacity to restore cancer chemotherapy damage. Currently, the most promising anti-aging therapy is melatonin, which has the ability to restore many physiologic processes.

Potential Patient Impact: This study has the potential to stop the cellular aging process that results from cancer treatment and prohibits complete restoration of the cell after treatment, thereby making it more susceptible to relapse and death. In addition, melatonin may improve progression- free survival and health-related quality of life as well as feelings of well being.

Autologous Dendritic Cell Vaccines in Non-Small Cell Lung Cancer (G-00-009). [Active Study]
Edward Hirschowitz, University of Kentucky Lexington, KY

The major goal of this study is to evaluate the cellular lung cancer vaccines.

Potential Patient Impact: Lung cancer is the leading cause of cancer deaths in the US. A vaccine would represent the greatest breakthrough in treatment in the past 30 years and a major contribution to cancer patients worldwide.

Melanoma Research

Combination Immunotherapies for Malignant Melanoma (G-03-038) [Active Study]
F. Stephen Hodi, Dana Farber/Harvard, Boston, MA

Despite convincing evidence for a patient’s ability to mount immune responses to a large number of cancers, most patients with advanced malignancies still succumb to their disease.

Potential Patient Impact: The incidence of malignant melanoma is increasing faster than any other cancer in the United States. Vaccine strategies to augment anti-melanoma immunity may prove therapeutic.

An Anti-Melanoma Vaccine based on Autologous Dendritic Cells Loaded with Allogeneic Standardized Lysate: Phase I/II Study (G-00-007). [Active Study]
Michal Lotem, Hadassah Medical Organization, Jerusalem, Israel

This project is to evaluate immunotherapy treatment using dendritic cells that have an enhanced ability to stimulate the immune system. The investigator will take the dendritic cells from patients with metastatic melanoma and treat them in the laboratory with melanoma extracts. They will then attack the tumor when reinjected back into the patient.

Potential Patient Impact: Melanoma is an ideal cancer to treat with immunotherapy. However, a useful vaccine has not yet been developed. This study has excellent potential as it uses dendritic cells, a novel method to enhance the vaccine process. Melanoma remains a deadly disease whose incidence has recently increased significantly. A vaccine would offer hope to many still dying despite earlier diagnosis.

Augmentation of Immune Response Against Metastatic Adeno Carcinoma by Vaccinations with Irradiated Semi-Allogeneic Cell Hybrids Formulated with Human GM-CSF (G-98-014)
Sebastiano Gattoni-Celli, Medical University of South Carolina, Charleston, SC

Patient Impact: This treatment has allowed many patients with melanoma to live much longer than expected. Mr. Hamlin is alive three years after treatment even though he was told he had less than six months to live. Dr. Gattoni-Celli published three articles in reputable, peer-reviewed journals.

Augmentation of Immune Response Against Metastatic Melanoma by Vaccination with Irradiated Tumor Cell Hybrids: A Phase I/II Pilot Study in Patients with Disseminated Melanoma (G-96-136)
Sebastiano Gattoni-Celli, Medical University of South Carolina, Charleston, SC

Patient Impact: The results showed a total lack of toxicity of this treatment that is capable of stimulating a specific cell-mediated immune response against melanoma tumor cells. Toxic therapy is a common reason for insufficient treatment and poor cure rates. Because the cancer treatment was well tolerated, patients in this study were able to complete the entire protocol. A manuscript was published in the respected Journal of Immunotherapy.

Antiangiogenic Therapy of Melanoma Precursor Lesions (G-96-027)
Dorthea Becker, University of Pittsburgh Cancer Institute, Pittsburgh, PA

Patient Impact: Data obtained from this study clearly indicate that interferon treatment inhibits the blood supply and growth pathways of melanoma precursor lesions. This potentially curative therapy has been published in two manuscripts in peer-reviewed journals. The investigator went on to receive National Cancer Institute funding after the promising work funded by CTRF

Multiple Myeloma Research

Sperm Protein 17 as a Tumor Vaccine in Multiple Myeloma (G-00-022). [Active Study]
Sean Lim, Texas Tech University, Amarillo, TX

Various studies have demonstrated the aberrant expression of normal testicular proteins in neoplastic cells. These proteins collectively form the new class of tumor antigens called cancer-testis (CT) antigens. Sp 17 is a novel member of the CT antigens and should be an ideal target for immunotherapy of multiple myeloma.

Potential Patient Impact: Multiple myeloma remains a deadly and painful disease. This study offers hope to those who suffer immeasurably from the effects of multiple myeloma including a life filled with frequent bone fractures that often occur with minimal activity.

Gene Therapy for Patients with Multiple Myeloma (G-99-015)
Thomas Kipps, University of California San Diego, San Diego, CA

Patient Impact: This study has served as the foundation for developing effective immune gene therapy for patients with this dreadful disease. A manuscript was published in the British Journal of Hematology, a well-known and respected journal in oncologic hematology.

Dexamethasone and 13-cis Retinoic Acid Therapy of Multiple Myeloma (G-97-004).
Mitchell Smith, Fox Chase Cancer Center, Philadelphia, PA

Patient Impact: This study evaluated the effects of dexamethasone and retinoic acid and found together they do inhibit melanoma cell growth. The important results of this study led to a four-institution trial for the further treatment of multiple myeloma. The results were presented at the International Myeloma Workshop.

The Impact of an Immunotoxin on Multiple Myeloma Patients with Minimal Residual Disease After Intensive Chemotherapy (G-95-003)
Ellen Vitetta, University of Texas Southwestern Medical Center, Dallas, TX

Patient Impact: Unfortunately this innovative treatment was not attractive enough to patients with multiple myeloma and the study had to be stopped due to poor enrollment. The remaining funds were returned to CTRF to benefit other researchers.

Nutrition

Effects of Multiple Antioxidants on Intermediate Cancer Risk Factors on Normal Human Subjects: a Pilot Study (G-00-012). [Active Study]
Zulema Coppes, Chemistry Facility, University Hospital, Montevideo, Uruguay

This study will help to define cancer intermediary risk factors such as oxidative stress in normal subjects. This information will help determine the potential value of multiple antioxidants in reducing levels of oxidative stress in cancer patients and promoting curative attempts.

Potential Patient Impact: This study will help define the appropriate dosing guidelines for antioxidants that are often used in excessive, dangerous levels by cancer patients as well as the general public.

Micronutrients as Adjuncts to Cancer Chemotherapy in Patients with Metastatic Disease: A Pilot Study (G-00-010)
James Stark, Cancer Treatment Centers of America, Portsmouth, VA

Patient Impact: This study provided valuable information regarding the measurement of antioxidant levels in patients receiving these important supplements during cancer treatment. Future studies will benefit significantly from this information.

Oral and Pharyngeal Head and Neck

Evaluation of Dietary Factors in Etiology of Oral and Pharyngeal Cancer in Gujarat, India (G-96-134)
Prabhudas Patel, Gujarat Cancer and Research Institute, Gujarat, India

Patient Impact: The findings of this study showed the potential role of vitamins in the prevention of oral and pharyngeal cancer. A decrease in the plasma vitamin levels was directly related to the advanced stage of cancer. Three publications, three awards, and three conference presentations with media coverage promoted CTRF and public awareness of the importance of dietary interventions in cancer prevention.

Zinc Supplementation Trial of Patients with Head and Neck Cancer (G-97-001)
Omer Kucuk, Wayne State University, Detroit, MI

Patient Impact: This study showed that zinc supplementation lowered the rate of infection and total hospital days in patients taking zinc. This has far-reaching implications not only for the patient’s quality of life but also for the potential to alter the death rate from cancer-related infection, which is the most common cause of death in cancer patients.

Ovarian Cancer Research

Correlative Study of Letrozole in Patients with Recurrent Advanced Borderline Tumors or Low Grade Epithelial Cancers of the Ovary, Fallopian Tube and Primary Peritoneum (G-04-051)
John J. Kavanagh, MD, University of Texas M.D. Anderson, Houston, TX

Borderline ovarian tumors – those with low malignant potential – account for 10-15% of ovarian cancers. Although this form of ovarian cancer generally has a good survival rate, borderline tumors that recur do not respond well to chemotherapy. Dr. Kavanagh is investigating whether the drug Letrozole, which inhibits estrogen production and has been useful in treating breast cancer, is effective in treating this type of ovarian cancer.

Potential Patient Impact: Treating borderline ovarian tumors, although not deadly, is key to eliminating recurring, more deadly, tumors in women. This study may be able to positively impact the recurrence rate and lead to greater survival rate.

Antioxidant Effects in the Treatment of Newly Diagnosed Ovarian Cancer When Added to First Line Chemotherapy (G-01-029). [Active Study]
Jeanne Drisko, University of Kansas Medical Center, Kansas City, KS

This is a study to evaluate the benefits of adding antioxidant therapy (vitamin C, E and others) to traditional chemotherapy in the treatment of ovarian cancer.

Potential Patient Impact: Ovarian cancer will strike close to 40,000 women this year – nearly 7,000 will die. The simple treatment proposed in this study has the potential to offer advanced treatment to these women and offer life to the many that would otherwise die.

Her-2/neu [HER2] Intracellular Domain Protein [ICD] Vaccines for the Prevention of Recurrences of HER-2 Overexpressing Breast Cancer and Ovarian Cancer (G-00-020). [Active Study – 2 tumor types]*
Mary [Nora] Disis, University of Washington Seattle, WA

Despite advances in surgery, chemotherapy and radiation, patients with breast and ovarian cancer may relapse because of residual microscopic disease. It is now known that certain proteins made by a cell can cause malignant transformation. These proteins can be recognized and targeted by the immune system much like an infectious disease. This study is developing a vaccine to eradicate residual sub-clinical breast cancer.

Potential Patient Impact: Breast cancer remains the most common cancer to effect American women. New treatments are desperately needed. This vaccine, by creating long lasting resistance to the outgrowth of residual tumor cells, offers hope to the 40,000 American women and many more worldwide who will die of breast cancer this year.

Improving Radioimmunotherapy of Ovarian Cancer with a Humanized, Engineered Antibody (G-98-010)
Ruby Meredith, University of Alabama, Birmingham, AL

Patient Impact: Although the prospects for this treatment were impressive, The National Cancer Institute never allowed the investigators to use the proposed antibody thus ending the study.

A Targeted Vector Strategy for Ovarian Cancer Gene Therapy (G-98-002)
David Curiel, University of Alabama, Birmingham, AL

Patient Impact: The FDA terminated all research for this study, as well as many others of this type nationwide due to fundamental questions about gene therapy in the US.

Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoetic Stem Cell Support in Women with Persistent, Refractory or Recurrent Advanced Epithelial Ovarian Cancer (G-97-022)
Amy Tiersten, Columbia Presbyterian Medical Center, New York, NY

Patient Impact: This study has had an important impact on women with ovarian cancer, a potentially deadly disease. One of the patients in the study is alive today due to the treatment she received on this CTRF-funded study.

Immunotherapy of Ovarian Cancer and Other Malignancies Expressing CEA Using Carcinoembryonic Antigen (CEA) Peptide-Pulsed Dendritic Cells (G-94-000)
Kim Lyerly, Duke University Medical Center, Durham, NC

Patient Impact: These results justify further investigation into this broadly applicable form of cancer immunotherapy. This study resulted in NIH recognition and support, and the construction of a commercial grade clinical cell-processing center that could be used by CTRF for the production of clinical grade biologics for other clinical investigators and patients.

Pancreatic Cancer Research

Correlative Studies in Pancreas Adjuvant Therapy (G-04-007)
David C. Linehan, MD, Washington University, St. Louis, MO

In this study, they propose to analyze blood taken from pancreas cancer patients before and after surgery, chemotherapy and radiation therapy in an attempt to identify protein expression patterns that are present when the tumor is, absent when the tumor is removed and present again in those patients whose disease recurs.

Potential Patient Impact: Such studies are the underpinnings of the future development of rapid, accurate, cost effective tests, which may dramatically change the way that disease is detected, monitored and treated.

Pediatric Cancer Research

Non-adherence and survival in adolescents with leukemia. The primary goal of this research is to determine the incidence of non-adherence to 6-mercaptopurine therapy in adolescents with acute lymphoblastic leukemia, identify the key factors associated with non-adherence and develop programs to prevent incomplete treatment. (G-02-035) [Active Study]
Eric Kodish, Case Western Reserve University, Cleveland, OH

Potential Patient Impact: Treatment advances for acute lymphoblastic leukemia in adolescents have dramatically increased survival. Unfortunately, the full benefit of these advances is only realized when the treatment course is followed closely and completed on schedule. Many young people neglect their daily medication for a variety of reasons. This problem results in relapse necessitating more toxic aggressive treatment and resulting in death for some. These investigators will evaluate this problem and develop lifesaving programs to eliminate non-adherence in adolescents with acute lymphoblastic leukemia.

Use of Phenylbutyrate in Pediatric Patients with Refractory Cancer (G-96-128)
Susan Blaney, Baylor College of Medicine, Houston, TX

Patient Impact: This study has provided benefit to children with recurrent cancer. An abstract was submitted to the 8th Int’l Meeting of Pediatric Neuro-Oncology, a prestigious conference bringing together pediatric oncologists from around the world.

Pre-Emptive Anti-Viral Therapy for Pediatric PTLD (G-96-104)
David Rowe, University of Pittsburgh, Pittsburgh, PA

Patient Impact: This study has shown that pre-emptive therapy significantly reduces morbidity and mortality following infection with Epstein-Barr virus (EBV). It has been established by others that the EBV may be the cause of certain cancers, making this study very important as a treatment modality in EBV-related cancers.

Pediatric Brain Cancer Research

A Transitional Phase I/II Study of Temozolomide or Lomustine Combined with Dietary Methionine Restriction for Recurrent Gliblastoma Multiforme (G-04-006)
Morris D. Groves, MD, MD Anderson Cancer Center, Houston, TX

Cancer patients will be treated with chemotherapy combined with a special diet, where the amino acid methionine is removed. The diet alone should cause some of the tumor cells to die, but combined with chemotherapy we expect a powerful anti-tumor effect in treating brain cancer.

Potential Patient Impact: The expected impact on patients is for their increased survival and quality of life from delay and prevention of tumor growth.

Evaluation of a Synthetic Vitamin A Compound in Children with Advanced Neuroblastoma (G-96-131)
Franca Formelli, National Cancer Institute, Milan, Italy

Patient Impact: Advanced neuroblastoma in children is a dreaded disease. In this study dose escalation to the maximal tolerated dose was achieved with pharmacokinetic studies being performed. The results showed that a potentially life-saving drug could be used safely in pediatric patients to control a highly aggressive tumor. An abstract was submitted to American Association for Cancer Research, a very large conference attended by cancer researchers throughout the world.

Prostate Cancer Research

A Phase II Study of the Combination of Bepridil and Trifluoperazine (G-98-003)
Roger Cohen, University of Virginia, Charlottesville, VA

Patient Impact: This study was stopped because the investigator moved but we have encouraged re-application. The idea is quite novel and represents an important, well-tolerated treatment for prostate cancer.

Antioxidant Vitamins and the Treatment of Human Prostate Cancer (G-97-019)
Ven Murthy, Laval University, Ste-Foy, Quebec

Patient Impact: There were promising results in the pre-clinical stage of this study but the investigator was unable to proceed to the patient enrollment stage. The study was closed and CTRF funding was returned.

Engineering IgTCR-modified T Cells for Prostate Therapy (G-96-114)
Richard Junghans, Deaconess Hospital, Boston, MA

Patient Impact: This study attempted to develop a special gene to fight prostate cancer. Unfortunately, federal regulations around gene therapy caused the early termination of the study and remaining CTRF funds were returned.

Chemoprevention of Prostate Cancer with Selenium Yeast (G-96-007)
Karam El-Bayoumy, American Health Foundation, Valhalla, NY

Patient Impact: These results demonstrate that selenium supplementation in healthy individuals effectively enhances blood GSH content and reduces the levels of oxidative stress. Further studies will evaluate the effect of selenium supplementation in prostate cancer patients or in subjects at high risk for prostate cancer, making this a safe and well-tolerated treatment modality.

Medical Food Supplementation and Prostate Cancer Study (G-95-002)
George Blackburn, Harvard Medical School/Beth Israel Deaconess Medical Center, Boston, MA

Patient Impact: The patients receiving Soy Protein Isolate (SPI) showed a significant decrease in linoleic acid and oleic acid in phospholipids, stearic acid and linoleic acid in cholesterol esters. These results support the combination of SPI supplement with a low fat diet to achieve lowering of serum fatty acids, an important aspect of cancer prevention. This work was presented at the American Society of Clinical Nutrition Conference in Montreal, Canada.

Renal Cell Cancer Research

Phase I study of adenoviral vector delivery of the Interleukin-12 gene in patients with metastatic renal cell carcinoma (G-02-028). [Active Study]
Robert Amato, Baylor College of Medicine, Houston, TX

In this study, the investigators will use a common, inactivated cold virus combined with a gene targeted to the cancer. The virus also carries a powerful anti-cancer agent called interleukin-12 to the cancer cells to destroy them. By using this method, the researchers are able to direct the treatment at the specific cancer cells and avoid the toxicity normally seen when exposing all cells (including normal cells) to the treatment such as in traditional chemotherapy.

Potential Patient Impact: Over 50,000 people in the United States will die from urologic cancers this year. Dr. Amato’s research offers a novel treatment to those with advanced renal cancer who would otherwise have no hope for cure.

Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy (G-99-021) [2 tumor types]*
Todd Zimmerman, University of Chicago, Chicago, IL

Patient Impact: 18 patients were enrolled. This study had the potential to treat renal cancer and melanoma. Like many aggressive studies, there was considerable risk to the patient and the study was terminated by the CTRF board.

Stem Cell Research

A Pilot Study of Adoptive Immunotherapy with Ex-Vivo Expanded NK-92 Cells in Stem Cell Transplant Patients at High Risk for Relapse (G-04-034)
Sally Arai, MD, Stanford University, Stanford, CA

Stem cell transplantation in high-risk disease patients is still burdened by high disease relapse rates. This project is the vital first step in the development of a novel natural killer cell-based therapy that will help prolong the survival and quality of life of these patients with highly resistant disease.

Potential Patient Impact: Using biologic immunotherapy to modulate the outcome of the transplant provides a unique approach with a different mode of action than conventional drugs

Quality of Life

(Assuring patients are better able to tolerate treatments and live longer with cancer)

The Efficacy of Gabapentin in the Treatment of Chemotherapy-Induced Neuropathy in Cancer Patients: A Randomized, Double-Blind, Placebo Controlled Trial (G-00-014). [Active Study]
Gilbert Wong, Mayo Clinic, Rochester, MN

The response to cancer chemotherapy can be one of the most important determinants of patient outcome and survival. However, certain treatments can affect the function of nerves resulting in unrelenting neuropathic pain. Anti-seizure drugs have been shown to be effective in non-cancer neuropathic pain. This study will evaluate the use of gabapentin for cancer-related neuropathy.

Potential Patient Impact: Gabapentin may prevent this nerve abnormality and allow patients to receive curative doses of chemotherapy.

The Effects of Aerobic Exercise on Quality of Life in Cancer Patients Following Clinical Treatment (G-01-017)
Tim Burnham, Central Washington University, Ellensburg, WA

In this study, one group will exercise three times a week at a low to moderate exercise intensity for twenty weeks while the other control group will go about their usual activity and not participate in the exercise program. Throughout the study, various physical and psychological tests will be performed, including a quality of life assessment.

Patient Impact: Thousands of cancer patients refuse curative therapy every year because they are not willing to endure the side effects. Exercise and its positive effects on physical well-being and quality of life may help control the devastating effects of cancer treatment and encourage patients to accept potentially curative therapies.

A Randomized Double-Blind Trial Using the Gastric Prokinetic Agent, Erythromycin, to Prevent Chemotherapy-Induced Nausea & Vomiting (G-99-016)
Randall Brand, University of Nebraska, Omaha, NE

Patient Impact: There was no difference in the nausea between the treatment group and the control group. However, there was a significant improvement in the overall nausea rate in the population, suggesting the study had an important impact on the standards of care.

Immunotherapies or Novel Treatments

Combination Immunotherapy for the Generation of HER-2/neu [HER2] Specific Cytoxic T Cells [CTL] in vivo (G-03-040) [Active Study]
Mary [Nora] Disis, University of Washington Seattle, WA

The HER2 protein is present in about 30% of breast cancers and has been shown to be able to stimulate immunity in patients with breast cancer. This novel approach includes the development of a vaccine to boost the low immunity level that is present in breast cancer patients.

Potential Patient Impact: If effective, this vaccine works to generate an immune response that will cause T cells to react and kill tumor cells. The goal is to immunize HER2 positive breast and ovarian cancer patients that are on Herceptin [a monoclonal antibody] and determine how the combination of the two approaches affects the immune system

A Phase I/II Trial of Transfer Factor and Intralymphatic Interleukin-2 in Patients with Stage D3 Prostate Cancer (G-01-002) [Active Study]
Giancarlo Pizza, Malpighi Hospital, Bologna, Italy,
Columbia Medical Center, New York, NY

This research study will combine two safe and effective immunological treatments previously found to be individually effective in the treatment of prostate cancer. According to the principle of synergy, two similar treatments which each have an effect by themselves, may have a very enhanced effect when combined.

Potential Patient Impact: Advanced prostate cancer that is unresponsive to hormonal treatment (the usual treatment) is a fatal disease. This new treatment testing the synergy of two treatments may help save the lives of over 30,000 men who will die of prostate cancer this year.

Breast

Leisha A. Emens, MD, PhD, The John Hopkins University, Baltimore, MD

Study: A Feasibility Trial of Cyclophosphamide-Modulated Vaccination with an Allogenic, GM-CSF-secreting Breast Cancer Vaccine in the Setting of Weekly Trastuzumab Therapy in Her-2/neu-negative and HER-2/neu-positive Metastataic Breast Cancer

This study will test a unique hormone-secreting, cell-based breast cancer vaccine in combination with immune-modulating doses of the chemotherapy drug Cyclophosphamide and standard dose Trastuzumab in patients with metastatic breast cancer.

Potential Patient Impact:  A robust T-cell response will develop and existing breast tumors will shrink.  May also provide critical data to accelerate the clinical development of vaccines for breast cancer and other cancers, paving the way for therapeutic cancer vaccines to become a unique but standard part of cancer care.

Stephen Ray, Christopher Lis, Cancer Treatment Centers of America, Zion, IL

Study: A Randomized Double Blind, Sham-Controlled, Pilot Clinical Trial Evaluating the Efficacy of Electroacupuncture in the Treatment of Chemotherapy-Induced Fatigue in Stage I-III Breast Cancer.

Fatigue is the most commonly reported side effect of cancer treatment.  This study will determine if electroacupuncture treatment can have a beneficial effect on cancer related fatigue, quality of sleep and activities of daily living.

Potential Patient Impact:  Research of cancer-related fatigue is in its infancy and future clinical trials examining the effects of pharmacologic and nonpharmacologic treatment therapies for cancer-related fatigue are needed.  Acupuncture is one such nonpharmacologic treatment that has been predicted to have a beneficial effect in the treatment of cancer related fatigue.

Leukemia / Lymphoma Research

Asher Chanan-Khan, Roswell Park Cancer Institute, Buffalo, NY

Study:  Randomized Phase II Study of Lenalidomide Alone vs. Lenalidomide in Combination with Fludarabine and Rituximab for Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL).

CLL is one of the most common leukemia that remains incurable with current therapies.  The novelty of this clinical trial resides not only in exploring a new agent in CLL but also that this is an oral, more convenient and expectantly less toxic regimen than conventional chemotherapy.

Potential Patient Impact: Targeting the microenvironment and the cytokine milieu can be an important approach to reverse the survival advantage and induce cell death in the CLL cell.

Multiple Myeloma Research

David Rizzieri, Duke University Medical Center, Durham, NC

Study:   Subcutaneous Delivery of Campath 1-H Monoclonal Antibody for the Treatment of Multiple Myeloma  (G-02-016)

This study proposes an immunological approach to effective anti-tumor therapy with few side effects and allows a significantly improved quality of life for multiple myeloma patients. A monoclonal antibody seeks out targets and, once bound to the cancer cell, uses the patient’s innate immune system to kill the cell as it would any object recognized as foreign to the body.

Potential Patient Impact:  Myeloma is one of the most common blood diseases in the Western hemisphere, attacking over 100,000 patients annually. The majority of patients are not candidates for aggressive therapies used to provide the longest remissions, and the average life span from diagnosis remains approximately only 3 years. If successful, this new treatment, researched for over 5 years, will be an effective therapy for myeloma and other types of lymphoma.

Sarcoma Research

Dimitry Gabrilovich, MD, PhD, H. Lee Moffitt Cancer Center, Tampa, FL

Study:  Combined treatment of soft tissue sarcoma.  Combination of External Beam Radiation with Intratumoral Injection of Dendritic Cells as Neo-Adjuvant Treatment of High Risk Soft Tissue Sarcoma Patients

Patients with high-grade large soft tissue sarcomas face a substantial risk of recurrence following standard local surgical therapy.  These patients have the greatest tendency for disease to metastasize or recur locally.

Potential Patient Impact:  Develop a new treatment approach for group of sarcoma patients who have a poor prognosis with standard therapy.  Additionally, determine if there is sufficient proof-of-principle for this approach to pursue its development in more common cancers.

Breast

William E. Gillanders, MD, Washington University School of Medicine, St. Louis, MO

Study: A Phase I Clinical Trial to Evaluate the Safety and Immunogenecity of a Mammaglobin-A DNA Vaccine in Stage IV Breast Cancer Patients

Mammaglobin-A is a gene that seems to be expressed only in breast tissue. Expression in breast cancer is much higher than in normal breast tissue. This Phase I trial is designed primarily to demonstrate the safety of a new drug, mammaglobin-A DNA vaccine. This vaccine was designed to generate an immune response to breast cancer.

Potential Patient Impact:  This vaccine would be an enormous breakthrough in breast cancer as mammaglobin-A is overexpressed in almost all breast cancers. If a successful vaccine is developed it can be used for all breast cancer patients by helping prevent recurrence.

Nutrition and Exercise

Heather Greenlee, ND, MPH, Mailman School of Public Health, Columbia University, New York, NY

Study: Effect of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Obesity is associated with hormonal profiles that are known to stimulate breast cancer growth, and as a consequence, obese women are at an increased risk of developing breast cancer compared to lean women.

Potential Patient Impact:  Easily accessible exercise facilities and nutritional instruction could have significant impact on the lives of cancer patients globally.

Sarcoma

Dimitry Gabrilovich, MD, PhD, H. Lee Moffitt Cancer Center, Tampa, FL

Study: Combination of External Beam Radiation with Intratumoral Injection of Dendritic Cells as Neo-Adjuvant Treatment of High Risk Soft Tissue Sarcoma Patients

Patients with high-grade large soft tissue sarcomas face a substantial risk of recurrence following standard local surgical therapy. These patients have the greatest tendency for disease to metastasize or recur locally.

Potential Patient Impact:  Develop a new treatment approach for a group of sarcoma patients who have a poor prognosis with standard therapy. Additionally, determine if there is sufficient proof-of-principle for this approach to pursue its development in more common cancers.