S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
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ClinicalTrials.gov Identifier: NCT00006020 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia | Drug: nelarabine | Phase 2 |
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 (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL) |
Study Start Date : | July 2000 |
Actual Primary Completion Date : | June 2004 |
Actual Study Completion Date : | July 2004 |

- Drug: nelarabine
1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
- CR [ Time Frame: After induction therapy is completed ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Diagnosis of acute lymphocytic leukemia (ALL)
- FAB class L1-L2
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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
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Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
- CD3 and myeloperoxidase marker negative
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006020

Study Chair: | Steven E. Coutre, MD | Stanford University |
Responsible Party: | Southwest Oncology Group |
ClinicalTrials.gov Identifier: | NCT00006020 History of Changes |
Other Study ID Numbers: |
S0010 S0010 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | March 6, 2015 |
Last Verified: | March 2015 |
recurrent adult acute lymphoblastic leukemia L1 adult acute lymphoblastic leukemia L2 adult acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia non-T, non-B adult acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |