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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 3-AP (Triapine® ) Followed By Fludarabine in Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndromes

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	JHOC-J0357 NCI-6255, NCT00077558, 6255

Trial Description

Purpose:

Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more cancer cells by making them more sensitive to the drug.

This phase I trial is studying the side effects and best dose of fludarabine when given together with 3-AP in treating patients with relapsed or refractory acute leukemia, chronic leukemia, or high-risk myelodysplastic syndrome.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• At least 1 week since biological therapy
• At least 3 days since hydroxyurea
• No more than 12 previous courses of fludarabine
• No more than three previous chemotherapy regimens
• At least 2 weeks since 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:

Some patients will receive a 4-hour infusion of 3-AP and an infusion of fludarabine on days 1-5. Other patients will receive a 24-hour continuous infusion of 3-AP on day 1 and an infusion of fludarabine on days 2-6. Treatment may be repeated every 3 weeks for as long as benefit is shown.

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Judith Karp, MD, Protocol chair		Ph: 410-502-7726

Registry Information
Official Title		A Phase I Trial Of Sequential Administration Of Triapine (3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone) Followed By Fludarabine In Adults With Relapsed And Refractory Leukemias And Myelodysplasias
Trial Start Date		2004-01-06
Registered in ClinicalTrials.gov		NCT00077558
Date Submitted to PDQ		2004-01-07
Information Last Verified		2005-11-07
NCI Grant/Contract Number		U01-CA70095, P30-CA06973

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