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

Alternate Title

Phase I/II Study of Flavopiridol in Patients With Refractory or Recurrent Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	NCI-07-C-0081 NCI-P7040, 7844, NCT00445341

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

This phase I/II trial is studying the side effects and best dose of flavopiridol and to see how well it works in treating patients with refractory or recurrent mantle cell lymphoma or diffuse large B-cell lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• More than 4 weeks since chemotherapy
• 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 4½-hour infusion of flavopiridol once a week for 4 weeks. Treatment may repeat every 6 weeks for up to six courses.

Patients will undergo blood sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated every 3-4 months until disease progression and periodically thereafter.

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

NCI - Center for Cancer Research

Kieron Dunleavy, MD, Protocol chair		Ph: 301-435-1007

U.S.A.
Maryland
	Bethesda
	NCI - Center for Cancer Research
		Clinical Trials Office - NCI - Center for Cancer Research	Ph:  888-624-1937
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Web site for additional information
Featured trial article

Registry Information
Official Title		A Phase I/II Study of Flavopiridol in Relapsed or Refractory Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma (DLBCL)
Trial Start Date		2007-02-01
Trial Completion Date		2009-11-17 (estimated)
Registered in ClinicalTrials.gov		NCT00445341
Date Submitted to PDQ		2007-01-19
Information Last Verified		2009-06-07

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