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.

Condition	Treatment or Intervention	Phase
recurrent adult acute lymphocytic leukemia	Drug: cyclophosphamide  Drug: cytarabine  Drug: dexamethasone  Drug: doxorubicin  Drug: etoposide  Drug: filgrastim  Drug: hydrocortisone  Drug: ifosfamide  Drug: leucovorin calcium  Drug: mesna  Drug: methotrexate  Drug: vincristine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• See Disease Characteristics

--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

North Carolina
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States

Study chairs or principal investigators

Bayard L. Powell,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000065137; CCCWFU-21195; NCI-V96-1062
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002865
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08