3-AP and Cytarabine in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: Cytarabine

Criteria

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