High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00002865
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of high-intensity, brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.
- Detailed Description
OBJECTIVES: I. Determine the complete response rate to high-intensity, brief-duration chemotherapy with cyclophosphamide, methotrexate, vincristine, doxorubicin, and dexamethasone followed by ifosfamide, methotrexate, vincristine, cytarabine, etoposide, and dexamethasone in patients with relapsed or refractory acute lymphocytic leukemia (ALL). II. Determine the toxic effects of these regimens in these patients.
OUTLINE: All patients receive up to six alternating courses (every 3-4 weeks) of two chemotherapy regimens: cyclophosphamide, oral dexamethasone, methotrexate with leucovorin rescue, vincristine, and doxorubicin over 5 days; and ifosfamide/mesna, oral dexamethasone, methotrexate with leucovorin rescue, vincristine, cytarabine, and etoposide over 5 days. G-CSF is given following each course until recovery of the neutrophil count. All patients receive triple intrathecal chemotherapy on day 1. Patients with CNS disease receive intrathecal therapy twice weekly until the CSF is clear, then weekly for 4 weeks, and monthly for 1 year; those who have not received prior CNS irradiation also receive whole-brain radiotherapy. Patients are followed monthly for 6 months, every 3 months for 18 months, every 6 months for 2 years, then annually.
PROJECTED ACCRUAL: A total of 37 evaluable patients will be accrued if at least 4 of the first 17 patients respond.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy 14 days evaluate adverse events after brief, high intensity chemotherapy 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States