Protocol Number: 06-C-0227

Title:

Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients with Hematologic Malignancies

Number:

06-C-0227

Summary:

Background:

-Fenretinide in pill form has killed or been shown to slow the growth of cancer cells in the laboratory. High doses of the drug were more effective at stopping cancer cells than lower doses; however, the higher doses of drug cannot be given in pill form.

-A new, intravenous (i.v.), form of the drug has been developed for giving it through the veins to permit higher doses.

Objectives:

-To find the highest safe dose of i.v. fenretinide that can be given to patients with blood or lymph node cancers and to examine the side effects of i.v. administration of the drug.

Eligibility:

-Patients 18 years of age and older with cancer of the blood or lymph nodes or with myeloproliferative disorders with a poor prognosis.

-Patients must have disease that is either resistant to treatment or has relapsed and for whom standard treatments are no longer effective.

Design:

-About 16 to 21 patients will participate in the study.

-The first patient in the study is given the lowest study dose of fenretinide. Subsequent patients receive increasingly higher doses as long as the side effects remain tolerable and until the maximum tolerated dose is reached.

-Fenretinide is given by continuous i.v. infusion over 5 days. If the side effects are tolerable and the disease does not worsen, a second dose is given 21 days after the first dose. Patients may receive a maximum of six 5-day infusions given every 21 days.

-Blood samples are collected frequently to determine how the body handles fenretinide and to monitor for drug side effects.

-Treatment response is monitored with physical examinations, blood and urine tests, imaging studies, such as CT and MRI scans, and possibly bone marrow biopsy or aspiration.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Retinoid

Cytotoxic

Lymphomas

Ceramide

Pharmacokinetics

Recruitment Keyword(s):

Hematologic Malignancy

Chronic Lymphocytic Leukemia

CLL

Chronic Myelogenous Leukemia

CML

Lymphoma

Non-Hodgkin Lymphoma

NHL

Condition(s):

Fenretinide

Investigational Drug(s):

Fenretinide (4-HPR)

Investigational Device(s):

None

Interventions:

Drug: Fenretinide (4-HPR)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Ponzoni M, Bocca P, Chiesa V, Decensi A, Pistoia V, Raffaghello L, Rozzo C, Montaldo PG. Differential effects of N-(4-hydroxyphenyl)retinamide and retinoic acid on neuroblastoma cells: apoptosis versus differentiation. Cancer Res. 1995 Feb 15;55(4):853-61.

Di Vinci A, Geido E, Infusini E, Giaretti W. Neuroblastoma cell apoptosis induced by the synthetic retinoid N-(4-hydroxyphenyl)retinamide.Int J Cancer. 1994 Nov 1;59(3):422-6.

Maurer BJ, Melton L, Billups C, Cabot MC, Reynolds CP. Synergistic cytotoxicity in solid tumor cell lines between N-(4-hydroxyphenyl)retinamide and modulators of ceramide metabolism. J Natl Cancer Inst. 2000 Dec 6;92(23):1897-909.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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