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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Study of FR901228 (Depsipeptide) Alone or in Combination With Rituximab and Fludarabine in Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	MSGCC-0307 NCI-6015, 6015, NCT00079443

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No CNS involvement
• More than 6 weeks since rituximab
• No previous donor stem cell transplantation
• More than 4 weeks since chemotherapy or radiation therapy
• No previous FR901228
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 4-hour infusion of FR901228 once a week for 3 weeks. Treatment may be repeated every 4 weeks for up to six courses. Some patients may then receive a 4- to 8-hour infusion of rituximab on day 1, an infusion of fludarabine on days 2-4, and a 4-hour infusion of FR901228 once a week for 3 weeks. Treatment may be repeated every 4 weeks for up to six courses. Patients will be evaluated periodically for up to 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Ashraf Badros, MD, Protocol chair		Ph: 410-328-2565; 800-888-8823

Registry Information
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
Trial Start Date		2004-02-25
Registered in ClinicalTrials.gov		NCT00079443
Date Submitted to PDQ		2004-02-05
Information Last Verified		2007-03-28
NCI Grant/Contract Number		CA69854

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