506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- Cancer Center and Beckman Research Institute, City of Hope
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Medical Center
- CCOP - Santa Rosa Memorial Hospital
- Stanford University
- David Grant Medical Center
- University of Colorado Cancer Center
- Veterans Affairs Medical Center - Denver
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- MBCCOP - University of Illinois at Chicago
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Henry Ford Hospital
- CCOP - Grand Rapids Clinical Oncology Program
- Providence Hospital - Southfield
- CCOP - Duluth
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Herbert Irving Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Barrett Cancer Center, The University Hospital
- Veterans Affairs Medical Center - Cincinnati
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- CCOP - Toledo Community Hospital Oncology Program
- Veterans Affairs Medical Center - Oklahoma City
- University of Oklahoma Health Sciences Center
- Oregon Cancer Center
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- CCOP - Greenville
- CCOP - Upstate Carolina
- Simmons Cancer Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Texas Tech University Health Science Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
- Madigan Army Medical Center
Arms of the Study
Arm 1
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.