ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

3-AP and Cytarabine in Treating Patients With Hematologic Cancer

This study is no longer recruiting patients.

Sponsored by: Vion Pharmaceuticals
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractoryhematologic cancer.

Condition Treatment or Intervention Phase
acute leukemia
atypical chronic myeloid leukemia
chronic leukemia
myelodysplastic and myeloproliferative disease
 Drug: 3-AP
 Drug: cytarabine
 Procedure: chemosensitization/potentiation
 Procedure: chemotherapy
 Procedure: enzyme inhibitor therapy
Phase I

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Pilot Study of 3-AP (Triapine®) and Cytarabine in Patients With Hematologic Malignancies

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a pilot, dose-escalation study of cytarabine.

Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response may receive an additional course as consolidation therapy.

Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients receive treatment at that dose.

PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location Information


Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4095,  United States

Study chairs or principal investigators

Mario Sznol, MD,  Study Chair,  Vion Pharmaceuticals   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000306465; VION-CLI-032; MDA-DM-030096
Record last reviewed:  September 2004
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064090
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act