506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
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Purpose
Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: nelarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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) |
| Enrollment: | 35 |
| Study Start Date: | August 1998 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: nelarabine |
Detailed Description:
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.
Eligibility| 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
- Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
- Creatinine clearance at least 50 mL/min (unless due to leukemia)
- 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
- No history of seizure disorder
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No concurrent erythropoietin
- No other concurrent chemotherapy
- No concurrent dexamethasone or other steroidal antiemetics
- No concurrent hormone therapy, except for non-disease-related conditions
Contacts and Locations
Show 91 Study Locations| Study Chair: | Daniel DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
| Study Chair: | Steven E. Coutre, MD | Stanford University |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003545 History of Changes |
| Other Study ID Numbers: | NCI-2012-01840, CLB-19801, SWOG-C19801, CDR0000066600 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013