Multi-Institutional Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Hematologic Malignancies
Protocol # 06-C-0227
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the treatment plan?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
Fenretinide (4-HPR) is a synthetic retinoid made in the late 1960s that has shown to be cytotoxic to a variety of cancer cell lines in vitro and induces cell death by several different mechanisms. It has been reported to have tumor inhibition in cell lines of leukemia/lymphoma, and in small cell and non-small cell lung cancer. There is good rationale to test 4-HPR against hematologic malignancies. The goal of the current study is to determine the tolerance of intravenous emulsion 4-HPR when given as a five-day continuous infusion and to determine, within the confines of a Phase I study, tumor response data. Data from this study may serve as a basis for future Phase II studies designed to determine the activity of intravenous 4-HPR against leukemia and lymphomas when used as a single agent.
Who is eligible for this trial? (PDQ)
- Histologically or cytologically confirmed diagnosis of one of the following hematologic malignancies:
- Non-Hodgkin's lymphoma
- Hodgkin's lymphoma
- Chronic hematologic malignancy with a poor prognosis including CLL, CML, indolent NHL and myeloproliferative disorders
- Refractory or relapsed disease as defined by one of the following:
- Resistant to standard therapy for refractory or relapsed disease
- Progressed after standard therapy for advanced disease
- Measurable or evaluable disease
- Previously treated leptomeningeal disease or brain metastasis allowed, provided there is no evidence of remaining cancer by position-emission tomography, MRI, or spinal fluid cytology
- No prior cranial radiotherapy
- No known allergy to egg products
What types of drugs or therapies are being used?
Fenretinide is a synthetic retinoid.
What is the treatment plan? (PDQ)
- Patients receive emulsified fenretinide IV continuously over 5 days
- Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
- Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair
- Cohorts of 1 patient receive accelerated escalating doses of fenretinide until 2 patients experience moderate toxicity (cumulative across all dose levels or 1 patient experiences dose-limiting toxicity [DLT])
- After completion of the accelerated dose-escalation portion, the standard dose-escalation portion begins
- Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined
- At least 6 patients are treated at the MTD
- After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter
What is the frequency and duration of the visits?
Time away from home per visit may be as long as 6 or 7 days. During this time, participants will be admitted to the hospital.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Anthony J. Murgo is Head of Early Clinical Trials Development in the NCI Division of Cancer Treatment and Diagnosis (DCTD) and Adjunct Investigator and Head of the Developmental Therapeutics Section in the Center for Cancer Research, Medical Oncology Branch. He is also Adjunct Professor of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Md.
Dr. Murgo received his M.D. and M.S. in Pathology and Immunology in 1975 from the State University of New York Downstate Medical Center. He completed a medical residency at Maimonides Medical Center in Brooklyn and a fellowship in Hematologic Oncology at Memorial Sloan-Kettering Cancer Center in New York City. Dr. Murgo is board certified in Internal Medicine and Medical Oncology and a Fellow of the American College of Physicians. He was on the faculty of West Virginia University School of Medicine where he was Professor of Medicine in the Section of Hematology/Oncology until 1989, at which time he joined the U.S. Food and Drug Administration as a medical officer in the Division of Oncologic Drug Products. In 1996 he continued in government service at the NCI. Prior to taking on his current position in the DCTD Office of the Director in 2005, Dr. Murgo was in the DCTD Cancer Therapy Evaluation Program (CTEP) as the Associate Branch Chief for Developmental Chemotherapy and Acting Chief of the Investigational Drug Branch. His current areas of research interest and specialization are investigational cancer drug development and early phase clinical trials. He has co-edited four books and authored more than 100 papers and book chapters.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Medical Oncology Branch and Affiliates, Developmental Therapeutics Section
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Anthony J. Murgo, M.D., M.S.
Principal Investigator
Phone: 301-496-4291
murgoa@mail.nih.gov
Referrals:
Janelle Bingham, R.N.
Referral Coordinator
Phone: 301-435-2715
jbingham@mail.nih.gov
Sonja Crandon, R.N.
Research Nurse
Phone: 301-594-4325
Fax: 301-480-7281
crandons@mail.nih.gov
Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
Phone: 301-451-1228
1-866-611-6310 (Toll Free)
Fax: 301-480-0919
ottenl@mail.nih.gov
Where can additional information be found?
Back to Top
