Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent small lymphocytic lymphoma, recurrent mantle cell lymphoma, Waldenstrom macroglobulinemia, adult grade III lymphomatoid granulomatosis, recurrent adult grade III lymphomatoid granulomatosis, secondary acute myeloid leukemia, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, refractory chronic lymphocytic leukemia, recurrent adult lymphoblastic lymphoma, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, chronic eosinophilic leukemia, primary myelofibrosis, chronic neutrophilic leukemia, essential thrombocythemia, polycythemia vera, stage II multiple myeloma, stage III multiple myeloma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent marginal zone lymphoma, splenic marginal zone lymphoma, recurrent adult acute myeloid leukemia
Eligibility Criteria
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
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- M. D. Anderson Cancer Center at University of Texas
- Joe Arrington Cancer Research and Treatment Center