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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000306465 | Registry Identifier | PDQ (Physician Data Query) | |
| MDA-DM-030096 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytarabine | Drug | |||
| triapine | Drug |
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:
Relapsed or refractory disease
Ineligible for higher priority protocols
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 1 week since prior growth factors, including the following:
No concurrent anticancer immunotherapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Mario Sznol, MD | Vion Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4095 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D001752 | Blast Crisis |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D009196 | Myeloproliferative Disorders |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| C078157 | 3-aminopyridine-2-carboxaldehyde thiosemicarbazone |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| D001855 | Bone Marrow Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |