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Spots Global Cancer Trial Database for Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

Official Title: TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY

Study ID: NCT00002704

Conditions

Leukemia

Study Description

Brief Summary: Phase II trial to study the effectiveness of radiation therapy following chemotherapy in treating children with CNS relapse from acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more cancer cells.

Detailed Description: OBJECTIVES: I. Determine the efficacy and toxicity of intensified systemic treatment with delayed central nervous system (CNS) irradiation in children with acute lymphoblastic leukemia and isolated CNS disease. II. Determine the efficacy of systemic thiotepa in reducing or clearing blasts in the cerebrospinal fluid of these patients. III. Evaluate the toxicity of single dose thiotepa followed by dexamethasone, vincristine, daunorubicin, and triple intrathecal therapy in these patients. IV. Determine the response rate of intrathecal sustained release cytarabine (DTC101) in patients with first bone marrow remission with first isolated CNS relapse. V. Assess the safety and toxicity of DTC101 in these patients. OUTLINE: Patients with significant neurologic symptoms (e.g., seizures, cranial nerve palsy, paresis, mental status changes) are entered directly on the Induction regimen and do not receive the Therapeutic Window. The following acronyms are used: ARA-C Cytarabine, NSC-63878 ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia) CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 DM Dexamethasone, NSC-34521 DNR Daunorubicin, NSC-82151 DTC101 Sustained release cytarabine G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 HC Hydrocortisone, NSC-10483 Mesna Mercaptoethane sulfonate, NSC-113891 MP Mercaptopurine, NSC-755 MTX Methotrexate, NSC-740 TIT Triple Intrathecal Therapy, IT MTX/IT HC/IT ARA-C TMP-SMX Trimethoprim-sulfamethoxazole TSPA Thiotepa, NSC-6396 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 THERAPEUTIC WINDOW: Single Agent Chemotherapy. TSPA or DTC101. \*\* Thiotepa window closed as of 7/6/98 \*\* \*\* DTC101 window opened 11/15/99 \*\* INDUCTION: 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. CONSOLIDATION: 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP; plus TIT. INTENSIFICATION I: 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT. RE-INDUCTION: 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. INTENSIFICATION II: 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT. CHEMORADIOTHERAPY: 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. MAINTENANCE: 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy. MP/MTX; alternating with CTX/VCR.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States

MBCCOP - University of South Alabama, Mobile, Alabama, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

University of California San Diego Cancer Center, La Jolla, California, United States

Lucile Packard Children's Hospital at Stanford, Palo Alto, California, United States

University of California Davis Medical Center, Sacramento, California, United States

Children's Hospital and Health Center, San Diego, California, United States

Yale Comprehensive Cancer Center, New Haven, Connecticut, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

Shands Hospital and Clinics, University of Florida, Gainesville, Florida, United States

Sylvester Cancer Center, University of Miami, Miami, Florida, United States

Miami Children's Hospital, Miami, Florida, United States

CCOP - Florida Pediatric, Tampa, Florida, United States

Emory University Hospital - Atlanta, Atlanta, Georgia, United States

Children's Memorial Hospital, Chicago, Chicago, Illinois, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana, United States

Tulane University School of Medicine, New Orleans, Louisiana, United States

CCOP - Ochsner, New Orleans, Louisiana, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

Johns Hopkins Oncology Center, Baltimore, Maryland, United States

Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

CCOP - Northern New Jersey, Hackensack, New Jersey, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Schneider Children's Hospital, New Hyde Park, New York, United States

Mount Sinai School of Medicine, New York, New York, United States

University of Rochester Cancer Center, Rochester, New York, United States

State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States

State University of New York - Upstate Medical University, Syracuse, New York, United States

Memorial Mission Hospital, Asheville, North Carolina, United States

Carolinas Medical Center, Charlotte, North Carolina, United States

Presbyterian Healthcare, Charlotte, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

East Carolina University School of Medicine, Greenville, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States

Oklahoma Memorial Hospital, Oklahoma City, Oklahoma, United States

CCOP - Columbia River Program, Portland, Oregon, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Children's Hospital of Greenville Hospital System, Greenville, South Carolina, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

Medical City Dallas Hospital, Dallas, Texas, United States

Simmons Cancer Center - Dallas, Dallas, Texas, United States

Baylor College of Medicine, Houston, Texas, United States

San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, United States

MBCCOP - South Texas Pediatric, San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States

Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States

Massey Cancer Center, Richmond, Virginia, United States

West Virginia University Hospitals, Morgantown, West Virginia, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States

Cross Cancer Institute, Edmonton, Alberta, Canada

McMaster Division, Hamilton, Ontario, Canada

Hospital for Sick Children, Toronto, Ontario, Canada

Montreal Children's Hospital, Montreal, Quebec, Canada

Hopital Sainte Justine, Montreal, Quebec, Canada

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico

Swiss Pediatric Oncology Group Bern, Bern, , Switzerland

Clinique de Pediatrie, Geneva, , Switzerland

Contact Details

Name: Julio C. Barredo, MD

Affiliation: Medical University of South Carolina

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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