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

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: nelarabine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006020

S0010 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.
• Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.

Enrollment: 35 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)