This trial is active, not recruiting.

Conditions chronic myeloproliferative disorders, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm
Treatment fenretinide
Phase phase 1
Sponsor California Cancer Consortium
Collaborator National Cancer Institute (NCI)
Start date February 2005
End date June 2017
Trial size 40 participants
Trial identifier NCT00104923, CCC-PHI-42, CDR0000413887, LAC-USC-0C-04-3, NCI-06-C-0227, NCI-6528, NCI-P6820, P30CA033572


RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fenretinide in a different way may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intravenous fenretinide in treating patients with refractory or relapsed hematologic cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To determine the maximum tolerated dose of fenretinide
time frame: participants will be followed for the duration of cycle 1, which is expected to be 3 weeks.
To describe the toxicities of fenretinide
time frame: participants will be followed for the duration of treatment, which is expected to be 18 weeks or less

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies: - Non-Hodgkin's lymphoma (NHL) - Hodgkin's lymphoma - Multiple myeloma - Acute lymphoblastic leukemia - Acute myeloid leukemia - Chronic hematologic malignancy with a poor prognosis (e.g., failed 3 prior standard therapies), including any of the following: - Chronic lymphocytic leukemia - Chronic myelogenous leukemia - Indolent NHL - Myeloproliferative disorders - Refractory or relapsed disease, as defined by 1 of the following: - Resistant to standard therapy for refractory or relapsed disease - Progressed after standard therapy for advanced disease - No effective treatment exists - Measurable or evaluable disease - No active CNS disease - Previously treated leptomeningeal disease or brain metastases allowed provided there is no evidence of remaining cancer by positron-emission tomography, MRI, or spinal fluid cytology PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 (unless due to bone marrow involvement of disease) - Platelet count ≥ 75,000/mm^3 (unless due to bone marrow involvement of disease) - Hemoglobin ≥ 8.0 g/dL (transfusion allowed) - No coagulation disorders Hepatic - AST and ALT < 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastasis) - Bilirubin ≤ 1.5 times ULN Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No major cardiovascular disease Pulmonary - No major respiratory disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception prior to study entry, during study, and for at least 6 months after study participation - No uncontrolled systemic infection - No uncontrolled hypertriglyceridemia (i.e., triglyceride level > 500 mg/dL) - No known HIV positivity - No known allergy to egg products - No known familial hyperlipidemia disorders - No previously undiscovered hypertriglyceridemia - No poorly controlled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 2 weeks since prior chemotherapy except hydroxyurea - No concurrent hydroxyurea during study drug administration - No other concurrent anticancer chemotherapy Endocrine therapy - No concurrent hormone-ablative agents - No concurrent steroids - No concurrent tamoxifen or any of its analogues Radiotherapy - No prior cranial radiotherapy - More than 2 weeks since prior radiotherapy Surgery - More than 20 days since prior surgery except for biopsy Other - Recovered from all prior therapy - More than 2 weeks since prior investigational agents - No other concurrent investigational agents - No other concurrent antineoplastic therapy - No other concurrent antioxidants - No concurrent herbal or other alternative therapies - No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E) - Standard dose multivitamin allowed - No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, or p-glycoprotein or multidrug resistance protein 1 (MRP1) drug/lipid transporters, including any of the following: - Cyclosporine or any of its analogues - Verapamil - Ketoconazole - Chlorpromazine - Mifepristone - Indomethacin - Sulfinpyrazone - No concurrent medications that may cause pseudotumor cerebri, including any of the following: - Tetracycline - Nalidixic acid - Nitrofurantoin - Phenytoin - Sulfonamides - Lithium - Amiodarone - No concurrent medication to control hypertriglyceridemia

Additional Information

Official title Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Hematologic Malignancies
Description OBJECTIVES: - Determine the maximum tolerated dose of intravenous emulsified fenretinide in patients with refractory or relapsed hematologic malignancies. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics and in vivo activity of this drug in these patients. - Determine, preliminarily, disease or tumor response in patients treated with this drug. OUTLINE: This is a pilot, dose-escalation, multicenter study. 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. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. At least 6 patients are treated at the MTD. An additional 12 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 then annually thereafter. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by California Cancer Consortium.