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

Alternate Title

Phase II Pilot Study of High-Dose Cytarabine and High-Dose Mitoxantrone in Patients With Recurrent or Refractory Leukemia or Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	55 and under	NCI	CWRU-5Y01 NCI-G02-2113, CWRU-11021P, NCT00047021, CASE-5Y01

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 56 years old
• At least 1 week 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 1-hour infusion of cytarabine on days 1-5 and an infusion of mitoxantrone on day 5. Patients will receive injections of sargramostim beginning 2 weeks after chemotherapy and continuing until blood counts return to normal. Some patients may receive a second course of treatment. All patients will be evaluated periodically for 3 months.

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

Ireland Cancer Center at University Hospitals/Case Medical Center

Mary Laughlin, MD, Protocol chair		Ph: 216-368-5693 Email: mjl13@po.cwru.edu

Registry Information
Official Title		A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
Trial Start Date		2001-11-30
Registered in ClinicalTrials.gov		NCT00047021
Date Submitted to PDQ		2002-08-08
Information Last Verified		2006-01-18
NCI Grant/Contract Number		P30-CA43703

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