S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
- Registration Number
- NCT00337168
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, 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 II trial is studying how well giving cytarabine together with clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.
- Detailed Description
Primary objective:
* Determine whether the complete remission rate in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) is sufficiently high after treatment with cytarabine and clofarabine to warrant further investigation.
Secondary objectives:
* Estimate the frequency and severity of toxicities associated with this dosing schedule of cytarabine and clofarabine.
* Investigate, preliminarily, the prognostic effects of cytogenetic features on response to treatment in these patients.
Other objectives (if funding allows):
* Investigate, preliminarily, the prognostic effects of laboratory correlates (expression of nucleoside transporters, expression of other pertinent genes by tissue microarray) and FISH features on response to treatment in these patients
OUTLINE: This is an open-label, multicenter study.
* Induction therapy (1 or 2 courses): Patients receive induction therapy comprising clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days 1-5 (course 1). Patients who achieve a response (5-25% blasts in the bone marrow with a ≥ 50% reduction in blasts from initial bone marrow aspirate) receive 1 more course of induction therapy beginning no later than day 45. Patients who achieve complete remission (\< 5% blasts in the bone marrow) after 1 or 2 courses of induction therapy may proceed to consolidation therapy.
* Consolidation therapy (1 course): Beginning within 60 days after the first day of the last induction therapy, patients may receive consolidation therapy comprising clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days 1-4.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Induc, ReInduc, Consol, clofarabine, cytarabine clofarabine Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4 Induc, ReInduc, Consol, clofarabine, cytarabine cytarabine Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4
- Primary Outcome Measures
Name Time Method Number of Patients With Complete Remission Between day 28 and day 35 inclusive Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease
- Secondary Outcome Measures
Name Time Method Expression of Nucleoside Transporters On average, two weeks before treatment started Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.
Number of Patients With Very Poor Risk Cytogenetics On average, 2 weeks before treatment started Toxicity Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Trial Locations
- Locations (91)
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Scroll for more (81 remaining)Providence Cancer Center🇺🇸Anchorage, Alaska, United States