Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, TdT positive childhood acute lymphoblastic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Acute lymphoblastic leukemia in first bone marrow remission (M1) with first isolated initial CNS relapse More than 5 WBC/microliter in cerebrospinal fluid (CSF) with blasts on cytospin OR immunophenotypic proof (encouraged) of relapse in CSF Identifiable blasts and presence on 2 CSF samples 3 weeks apart If B-cell terminal deoxynucleotidyl transferase (TdT) OR CD-10 If T-cell TdT alone OR with CD-7 PATIENT CHARACTERISTICS: Age: Over 6 months and under 21 years at relapse Patients receiving sustained release cytarabine Performance status: Older than 10 years Karnofsky greater than 50% Less than 10 years Lansky greater than 50% Platelet count greater than 40,000/mm3 Bilirubin less than 2.0 mg/dL SGPT less than 5 times normal Creatinine less than 1.5 times normal for age Normal metabolic parameters (serum electrolytes, calcium, and phosphorus) No clinical evidence of obstructive hydrocephalus, compartmentalization of the CSF flow, ventriculoperitoneal or ventriculoatrial shunt PRIOR CONCURRENT THERAPY: Prior cumulative anthracycline dose less than 375 mg/sqm Patients receiving sustained release cytarabine At least 7 days since prior investigational drug At least 3 weeks since prior CNS directed therapy (6 weeks is prior nitrosourea) At least 1 week since intrathecal chemotherapy At least 8 weeks since prior craniospinal radiotherapy
Sites / Locations
- University of Alabama Comprehensive Cancer Center
- MBCCOP - University of South Alabama
- University of Arkansas for Medical Sciences
- University of California San Diego Cancer Center
- Lucile Packard Children's Hospital at Stanford
- University of California Davis Medical Center
- Children's Hospital and Health Center
- Yale Comprehensive Cancer Center
- Walter Reed Army Medical Center
- Shands Hospital and Clinics, University of Florida
- Sylvester Cancer Center, University of Miami
- Miami Children's Hospital
- CCOP - Florida Pediatric
- Emory University Hospital - Atlanta
- Children's Memorial Hospital, Chicago
- University of Kansas Medical Center
- CCOP - Wichita
- Via Christi Regional Medical Center
- MBCCOP - LSU Medical Center
- Tulane University School of Medicine
- CCOP - Ochsner
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Johns Hopkins Oncology Center
- Boston Floating Hospital Infants and Children
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center
- Children's Hospital of Michigan
- University of Mississippi Medical Center
- Cardinal Glennon Children's Hospital
- Washington University School of Medicine
- CCOP - Northern New Jersey
- Hackensack University Medical Center
- Roswell Park Cancer Institute
- Schneider Children's Hospital
- Mount Sinai School of Medicine
- University of Rochester Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- State University of New York - Upstate Medical University
- Memorial Mission Hospital
- Carolinas Medical Center
- Presbyterian Healthcare
- Duke Comprehensive Cancer Center
- East Carolina University School of Medicine
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Oklahoma Memorial Hospital
- CCOP - Columbia River Program
- St. Christopher's Hospital for Children
- Rhode Island Hospital
- Medical University of South Carolina
- Children's Hospital of Greenville Hospital System
- Saint Jude Children's Research Hospital
- Medical City Dallas Hospital
- Simmons Cancer Center - Dallas
- Baylor College of Medicine
- San Antonio Military Pediatric Cancer and Blood Disorders Center
- MBCCOP - South Texas Pediatric
- University of Texas Health Science Center at San Antonio
- Cancer Center, University of Virginia HSC
- Naval Medical Center, Portsmouth
- Massey Cancer Center
- West Virginia University Hospitals
- Midwest Children's Cancer Center
- Cross Cancer Institute
- McMaster Division
- Hospital for Sick Children
- Montreal Children's Hospital
- Hopital Sainte Justine
- University of Puerto Rico School of Medicine Medical Sciences Campus
- Swiss Pediatric Oncology Group Bern
- Clinique de Pediatrie
Arms of the Study
Arm 1
Experimental
Arm I
Single Agent Chemotherapy. TSPA or DTC101. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP; plus TIT. 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT. Radiotherapy plus 3-Drug Combination Chemotherapy. Craniospinal irradiation using x-rays with energies of 4-6 MV (electrons acceptable for spinal cord irradiation); plus ASP/DM/VCR. 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy. MP/MTX; alternating with CTX/VCR.