NCT00006020

S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

Official Title:

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: nelarabine
    • Description: 1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network