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FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma

2014-08-27 03:54:31 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- Determine the clinical efficacy of single-agent FR901228 (depsipeptide), in terms of complete and partial response rates, in patients with relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. (Phase II)

- Determine the feasibility of adding FR901228 to a rituximab and fludarabine combination regimen in these patients. (Phase I)

- Determine the maximum tolerated dose of FR901228 when administered with this combination regimen in these patients. (Phase I)

Secondary

- Correlate changes in histone acetylation assays with disease response (clinical outcome) in patients treated with this regimen.

- Determine the minimal residual disease by immunohistochemistry in patients treated with this regimen.

OUTLINE: This is a multicenter, phase II study of single-agent FR901228 followed by a phase I, dose-escalation study of FR901228.

- Phase II: Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve a complete or partial remission receive 2 additional courses (for a total of 6 courses). Patients with stable disease after 4 courses or progressive disease at any time after 2 courses proceed to the phase I portion of the study.

- Phase I: Patients receive rituximab IV over approximately 4-8 hours on day 1; fludarabine IV over 10-30 minutes on days 2-4; and FR901228 IV over 4 hours on days 2, 9, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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.

Study Design

Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

rituximab, fludarabine phosphate, romidepsin

Location

Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore
Maryland
United States
21201

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:31-0400

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An enzyme of the transferase class that catalyzes the reaction sedoheptulose 7-phosphate and D-glyceraldehyde 3-phosphate to yield D-erythrose 4-phosphate and D-fructose phosphate in the PENTOSE PHOSPHATE PATHWAY. (Dorland, 27th ed) EC 2.2.1.2.

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