High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 8/12/2018 |
| Start Date: | April 1995 |
| End Date: | August 2001 |
HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN
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.
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.
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.
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.
DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia that is
relapsed after or refractory to induction therapy 1 or 2 prior inductions allowed, but
refractory to only 1 regimen CNS involvement allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-3 Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 1.5 times normal (unless directly attributable
to leukemia) Renal: Creatinine no greater than 1.5 times normal (unless directly
attributable to leukemia) Cardiovascular: No uncontrolled or severe cardiovascular disease
including: Myocardial infarction within 6 months Congestive heart failure Other: No
uncontrolled duodenal ulcer No uncontrolled infection No second malignancy within 5 years
except curatively treated: In situ cervical cancer Basal cell skin cancer No other serious
medical illness that would limit survival to under 2 years No psychiatric illness that
would prevent informed consent or compliance No pregnant or nursing women Adequate
contraception required of fertile patients
PRIOR CONCURRENT THERAPY: See Disease Characteristics
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Winston-Salem, North Carolina 27157
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