- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00064090
3-AP and Cytarabine in Treating Patients With Hematologic Cancer
A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies
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 refractory hematologic cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the feasibility, tolerability, and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies.
- Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients.
- Determine the biological effects of 3-AP and its interaction with cytarabine in these patients.
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030-4095
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia
- Acute lymphoblastic leukemia
- Chronic myelogenous leukemia (CML)
- CML in blast crisis
- Chronic lymphocytic leukemia
High-risk* myelodysplastic syndromes, including the following:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia NOTE: *High-risk myelodysplasia defined as having an International Performance Scoring System score of at least 1.5, based on adverse cytogenetics, greater than 10% blasts in marrow, and cytopenias in at least 2 lineages
- Relapsed or refractory disease
- Ineligible for higher priority protocols
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 2 months
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin no greater than 2.0 mg/dL (unless considered due to malignancy)
- ALT or AST no greater than 3 times upper limit of normal
- Chronic hepatitis allowed
Renal
- Creatinine no greater than 2.0 mg/dL (unless considered due to malignancy)
Cardiovascular
- No myocardial infarction within the past 3 months
- No symptomatic coronary artery disease
- No arrhythmias (other than atrial fibrillation or flutter) requiring treatment
- No uncontrolled congestive heart failure
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Concurrent infections under active treatment with and controlled by antibiotics allowed
- No other concurrent life-threatening illness
- No mental deficit or psychiatric history that would preclude giving informed consent or complying with protocol
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 1 week since prior growth factors, including the following:
- Epoetin alfa
- Filgrastim (G-CSF)
- Sargramostim (GM-CSF)
- Interleukin-3
- Interleukin-11
- No concurrent anticancer immunotherapy
Chemotherapy
- At least 72 hours since prior hydroxyurea
- Recovered from prior chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 2 weeks since prior radiotherapy
- No concurrent anticancer radiotherapy
Surgery
- Not specified
Other
- At least 3 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease)
- At least 1 week since prior nonmyelosuppressive therapy
- No other concurrent standard or investigational therapy for the malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- chronic myelomonocytic leukemia
- previously treated myelodysplastic syndromes
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- recurrent adult acute myeloid leukemia
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- refractory chronic lymphocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- atypical chronic myeloid leukemia, BCR-ABL1 negative
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Myelodysplastic Syndromes
- Leukemia
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- VION-CLI-032
- CDR0000306465 (Registry Identifier: PDQ (Physician Data Query))
- MDA-DM-030096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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