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Investigator(s):
Anthony J.  Murgo, M.D., M.S. Principal Investigator Phone: 301-496-4291 murgoa@mail.nih.gov
Referral Contact(s):
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

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Primary Eligibility:

• 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

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Treatment Plan:

• 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

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 10/14/08
Updated: 10/14/08