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

• ClinicalTrials.gov Identifier: NCT00006020
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: March 6, 2015
• Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Southwest Oncology Group

Tracking Information

• First Submitted Date: July 5, 2000
• First Posted Date: January 27, 2003
• Last Update Posted Date: March 6, 2015
• Study Start Date: July 2000
• Actual Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 12, 2012): CR [ Time Frame: After induction therapy is completed ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)

Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leukemia

Intervention

Drug: nelarabine

1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 14, 2011): 35
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2004
• Actual Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00006020
• Other Study ID Numbers: S0010; S0010 ( Other Identifier: SWOG ); U10CA032102 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Southwest Oncology Group
• Study Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Steven E. Coutre, MD; Stanford University

• PRS Account: Southwest Oncology Group
• Verification Date: March 2015