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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003545 |
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 with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: nelarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL) |
Estimated Enrollment: | 35 |
Study Start Date: | August 1998 |
OBJECTIVES: I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5). II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.
OUTLINE: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 2.5-3 years, at a rate of 12-15 patients per year.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8 Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13 Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia) Renal: Creatinine clearance at least 50 mL/min (unless due to leukemia) Neurologic: No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL No preexisting neuropathy of grade 2 or greater regardless of causality Other: No history of seizure disorder Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent erythropoietin Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent dexamethasone or other steroidal antiemetics No concurrent hormone therapy, except for non-disease-related conditions Radiotherapy: See Disease Characteristics Surgery: Not specified
Study Chair: | Daniel DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
Study Chair: | Steven E. Coutre, MD | Stanford University |
Study ID Numbers: | CDR0000066600, CLB-19801, SWOG-C19801 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003545 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma recurrent adult acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia |
T-cell adult acute lymphoblastic leukemia recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Lymphoblastic lymphoma Recurrence Acute lymphoblastic leukemia, adult |
Leukemia Lymphatic Diseases Leukemia, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |