Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer

NCT00104923 | Completed Phase 1 DMC

• 7 other identifiers: CDR0000413887P30CA033572CCC-PHI-42NCI-6528LAC-USC-0C-04-3NCI-06-C-0227NCI-P6820
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (2)

• To determine the maximum tolerated dose of fenretinide

  participants will be followed for the duration of cycle 1, which is expected to be 3 weeks.

• To describe the toxicities of fenretinide

  participants will be followed for the duration of treatment, which is expected to be 18 weeks or less

Interventions

fenretinide DRUG

Current dose level as an IV continuous infusion via central line over 5 days. Cycle is repeated every 3 weeks for up to 6 cycles

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• California Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Congenital Abnormalities; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Burkitt Lymphoma; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hodgkin Disease; Pdgfra-Associated Chronic Eosinophilic Leukemia; Primary Myelofibrosis; Leukemia, Neutrophilic, Chronic; Thrombocythemia, Essential; Polycythemia Vera; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Leukemia, Myeloid, Acute

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Ann Mohrbacher, MD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (4)