NCT00293410

Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia, or Myeloproliferative Disorders

Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myeloproliferative disorders.

Detailed description

OBJECTIVES: Primary * Determine the feasibility and tolerability of administering clofarabine and fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or high-risk myeloproliferative disorders * Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide in these patients. * Determine the toxic effects of these drugs in these patients. Secondary * Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on marrow and circulating leukemic blasts in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to age (adult vs child). Patients receive cyclophosphamide IV over 2 hours on day 0. Patients then receive clofarabine IV over 2 hours and cyclophosphamide IV over 2 hours on days 1-3 and 8-10. Treatment with clofarabine and cyclophosphamide repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of clofarabine and cyclophosphamide 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. At least 10 patients are treated at the MTD. After completion of study treatment, patients are followed periodically for 1 year. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
DRUG	clofarabine
DRUG	cyclophosphamide

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-04-01
• First posted: 2006-02-17
• Last updated: 2010-05-06

Locations

1 site across 1 country: United States