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| Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079443 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as FR901228 and fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Rituximab may increase the effectiveness of chemotherapy drugs by making cancer cells more sensitive to the drugs.
PURPOSE: This phase I/II trial is studying the best dose of FR901228 when given together with rituximab and fludarabine and to see how well FR901228 works alone in treating patients with relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: fludarabine phosphate Drug: romidepsin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Single Agent Depsipeptide (NSC 63017) Followed by a Phase I Study of Rituximab/Fludarabine Combination With an Escalating Dose of Depsipeptide in Relapsed or Refractory Low Grade B- Cell Lymphomas |
| Estimated Enrollment: | 36 |
| Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase II study of single-agent FR901228 followed by a phase I, dose-escalation study of FR901228.
Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for up to 3 years from study entry.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for the phase II portion of this study within 9 months. A total of 3-24 patients will be accrued for the phase I portion of this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically and clinically confirmed low-grade follicular B-cell non-Hodgkin's lymphoma (NHL), including the following subtypes:
Relapsed and/or refractory disease
Received at least 1, but no more than 4, prior chemotherapy regimens for low-grade follicular NHL
For phase I, prior rituximab and fludarabine must not have been administered in combination or sequentially
Measurable disease 4 weeks after the last chemotherapy regimen, meeting at least 1 of the following criteria:
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No EKG abnormality (i.e., ischemic ST-T abnormalities, QT prolongation, pathologic q waves, or arrhythmias)
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Study Chair: | Ashraf Z. Badros, MD | University of Maryland Greenebaum Cancer Center |
More Information
| Study ID Numbers: | CDR0000355763, MSGCC-0307, NCI-6015 |
| Study First Received: | March 8, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079443 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent small lymphocytic lymphoma |
|
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Follicular Romidepsin Fludarabine monophosphate Immunosuppressive Agents Follicular Lymphoma Recurrence Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse |
Anti-Bacterial Agents Lymphatic Diseases Chronic Lymphocytic Leukemia B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Antirheumatic Agents Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs Romidepsin Fludarabine monophosphate |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Fludarabine Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |