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

Alternate Title

Phase I Study of Flavopiridol in Patients With Metastatic or Unresectable Refractory Solid Tumors or Hematologic Malignancies (Accrual for patients with hematologic malignancies temporarily closed as of 11/30/04)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Temporarily closed	18 and over	NCI	DFCI-03082 NCI-6052, NCT00070239, 6052

Trial Description

Purpose:

Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die.

This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with metastatic or unresectable refractory solid tumors or hematologic malignancies.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• At least 4 weeks since monoclonal antibody therapy
• At least 3 weeks since chemotherapy or radiation therapy
• 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 1- to 6-hour infusion of flavopiridol once a week or once every other week for 3 weeks. Treatment may be repeated every 4 weeks for as long as benefit is shown. Patients will be evaluated at 1 month and every 2 months 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

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Geoffrey Shapiro, MD, PhD, Principal investigator		Ph: 617-632-4942; 866-790-4500 Email: geoffrey_shapiro@dfci.harvard.edu

Registry Information
Official Title		A Phase I Clinical, Pharmacokinetic, and Pharmacodynamic Study of Novel Flavopiridol in Patients With Refractory Solid Tumors and Hematologic Malignancies
Trial Start Date		2003-10-03
Trial Completion Date		2006-06-29 (estimated)
Registered in ClinicalTrials.gov		NCT00070239
Date Submitted to PDQ		2003-08-21
Information Last Verified		2008-06-01
NCI Grant/Contract Number		CA06516, CA62490

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