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3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
This study has been completed.
Study NCT00077181   Information provided by National Cancer Institute (NCI)
First Received: February 10, 2004   Last Updated: July 23, 2008   History of Changes

February 10, 2004
July 23, 2008
December 2003
July 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00077181 on ClinicalTrials.gov Archive Site
 
 
 
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies

RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies.

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of 3-AP (Triapine®) administered with high-dose cytarabine in patients with advanced hematologic malignancies.

Secondary

  • Determine the clinical activity of this regimen in these patients.
  • Determine the effect of treatment with 3-AP (Triapine®) on intracellular levels of cytarabine in these patients.

OUTLINE: This is a dose-escalation study of 3-AP (Triapine®).

Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP (Triapine®) IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per stratum) will be accrued for this study within 15-24 months.

Phase I
Interventional
Treatment
Leukemia
  • Drug: cytarabine
  • Drug: triapine
 
Odenike OM, Larson RA, Gajria D, Dolan ME, Delaney SM, Karrison TG, Ratain MJ, Stock W. Phase I study of the ribonucleotide reductase inhibitor 3-aminopyridine-2-carboxaldehyde-thiosemicarbazone (3-AP) in combination with high dose cytarabine in patients with advanced myeloid leukemia. Invest New Drugs. 2008 Jun;26(3):233-9. Epub 2008 Jan 24.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following hematologic malignancies:

    • Relapsed or refractory acute myeloid leukemia (AML)
    • Relapsed or refractory acute lymphoblastic leukemia
    • Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML
    • Chronic myeloid leukemia in accelerated or blast phase
  • Refractory to standard therapy or no standard therapy exists
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • CALGB 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • No G6PD deficiency

Hepatic

  • Bilirubin < 2.0 mg/dL (unless due to Gilbert's syndrome)
  • AST and ALT < 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine < 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Pulmonary

  • No pulmonary disease requiring oxygen

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs
  • No neuropathy
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic agents

Chemotherapy

  • At least 72 hours since prior hydroxyurea
  • At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077181
 
CDR0000349659, UCCRC-12806B, NCI-6283
University of Chicago
National Cancer Institute (NCI)
Principal Investigator: Olatoyosi M. Odenike, MD University of Chicago
National Cancer Institute (NCI)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP