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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006020
First received: July 5, 2000
Last updated: January 12, 2012
Last verified: January 2012

July 5, 2000
January 12, 2012
July 2000
June 2004   (final data collection date for primary outcome measure)
CR [ Time Frame: After induction therapy is completed ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00006020 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
Drug: nelarabine
1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 2004
June 2004   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006020
CDR0000068032, S0010, U10CA032102
Not Provided
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Steven E. Coutre, MD Stanford University
Southwest Oncology Group
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP