3-AP and Cytarabine in Treating Patients With Hematologic Cancer

NCT00064090 | Completed Phase 1

• 3 other identifiers: VION-CLI-032CDR0000306465MDA-DM-030096
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Keywords

recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; blastic phase chronic myelogenous leukemia; refractory chronic lymphocytic leukemia; relapsing chronic myelogenous leukemia; chronic myelomonocytic leukemia; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; previously treated myelodysplastic syndromes; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

cytarabine DRUG

triapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Blast Crisis; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelomonocytic, Chronic; Anemia, Refractory, with Excess of Blasts; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Myeloproliferative Disorders; Congenital Abnormalities

Interventions

Cytarabine; 3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Anemia, Refractory; Anemia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mario Sznol, MD

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: March 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: January 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2008-08

Locations

US (1)