NCT00006020
S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
PHASE2
COMPLETED
NCT00006020
INTERVENTIONAL
A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphocytic leukemia (ALL)
* FAB class L1-L2
* Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)
* Coexpression of myeloid antigens CD13 or CD33 allowed
* Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
* CD3 and myeloperoxidase marker negative
* Meeting 1 of the following criteria for recurrent/refractory disease:
* Refractory to standard induction regimen including at least vincristine and prednisone
* Recurrence after response after prior induction therapy
* Recurrence and failure on subsequent treatment
* No CNS involvement
* Must be registered on SWOG-S9910 and SWOG-9007
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Zubrod 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 3 times ULN
Renal:
* Creatinine no greater than 2 times ULN
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater neuropathy
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Leukemia
- TREATMENT
-
- Type: DRUG
- Name: nelarabine
- Description: 1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
- Arm Group Labels:
- SWOG Cancer Research Network