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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104923 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Drug: fenretinide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Hematologic Malignancies |
Estimated Enrollment: | 21 |
Study Start Date: | February 2005 |
Estimated Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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 16-21 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
Chronic hematologic malignancy with a poor prognosis (e.g., failed 3 prior standard therapies), including any of the following:
Refractory or relapsed disease, as defined by 1 of the following:
No active CNS disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 2 weeks since prior chemotherapy except hydroxyurea
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)
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:
No concurrent medications that may cause pseudotumor cerebri, including any of the following:
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Allen S. Yang, MD, PhD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000413887, CCC-PHI-42, NCI-6528, LAC-USC-0C-04-3, NCI-06-C-0227, NCI-P6820 |
Study First Received: | March 3, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00104923 |
Health Authority: | Unspecified |
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 chronic idiopathic myelofibrosis chronic neutrophilic leukemia essential thrombocythemia polycythemia vera stage II multiple myeloma stage III multiple myeloma recurrent adult diffuse large cell lymphoma |
Polycythemia Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Hemorrhagic thrombocythemia Neoplasm Metastasis Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Hodgkin Disease |
Essential thrombocytosis Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Waldenstrom Macroglobulinemia B-cell lymphomas Lymphoma, Non-Hodgkin |
Anticarcinogenic Agents Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases Protective Agents Pharmacologic Actions |