HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy
Bayard L. Powell, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center||Winston-Salem, North Carolina 27157-1082|