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

NCT00002704 | Completed Phase 2

• 3 other identifiers: NCI-2012-01528POG-9412CDR0000064509
• Study Type: interventional
• Target: 156
• Locations: 4 countries
• Sites: 70

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.

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia; TdT positive childhood acute lymphoblastic leukemia

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: leucovorin calcium; Drug: liposomal cytarabine; Drug: mercaptopurine; Drug: mesna; Drug: methotrexate; Drug: therapeutic hydrocortisone; Drug: thiotepa; Drug: vincristine sulfate; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy

Interventions

filgrastim BIOLOGICAL

Arm I

asparaginase DRUG

Arm I

cyclophosphamide DRUG

Arm I

daunorubicin hydrochloride DRUG

Arm I

dexamethasone DRUG

Arm I

etoposide DRUG

Arm I

leucovorin calcium DRUG

Arm I

liposomal cytarabine DRUG

Arm I

mercaptopurine DRUG

Arm I

mesna DRUG

Arm I

methotrexate DRUG

Arm I

therapeutic hydrocortisone DRUG

Arm I

thiotepa DRUG

Arm I

vincristine sulfate DRUG

Arm I

low-LET electron therapy RADIATION

Arm I

low-LET photon therapy RADIATION

Arm I

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (70)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MBCCOP - University of South Alabama

Mobile, Alabama, 36688, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Children's Hospital and Health Center

San Diego, California, 92123-4282, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

CCOP - Florida Pediatric

Tampa, Florida, 33682-7757, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Boston Floating Hospital Infants and Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-9832, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Memorial Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Healthcare

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Oklahoma Memorial Hospital

Oklahoma City, Oklahoma, 73126-0307, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

MBCCOP - South Texas Pediatric

San Antonio, Texas, 78284-7810, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Cancer Center, University of Virginia HSC

Charlottesville, Virginia, 22908, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9162, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

McMaster Division

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Swiss Pediatric Oncology Group Bern

Bern, CH 3010, Switzerland

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

Related Publications (2)

• Eapen M, Zhang MJ, Devidas M, Raetz E, Barredo JC, Ritchey AK, Godder K, Grupp S, Lewis VA, Malloy K, Carroll WL, Davies SM, Camitta BM; Children's Oncology Group; Center for International Blood and Marrow Transplant Research. Outcomes after HLA-matched sibling transplantation or chemotherapy in children with acute lymphoblastic leukemia in a second remission after an isolated central nervous system relapse: a collaborative study of the Children's Oncology Group and the Center for International Blood and Marrow Transplant Research. Leukemia. 2008 Feb;22(2):281-6. doi: 10.1038/sj.leu.2405037. Epub 2007 Nov 22.

  PMID: 18033318 BACKGROUND

• Barredo JC, Devidas M, Lauer SJ, Billett A, Marymont M, Pullen J, Camitta B, Winick N, Carroll W, Ritchey AK. Isolated CNS relapse of acute lymphoblastic leukemia treated with intensive systemic chemotherapy and delayed CNS radiation: a pediatric oncology group study. J Clin Oncol. 2006 Jul 1;24(19):3142-9. doi: 10.1200/JCO.2005.03.3373.

  PMID: 16809737 RESULT

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Filgrastim; Asparaginase; Cyclophosphamide; Daunorubicin; Dexamethasone; Etoposide; Leucovorin; Mercaptopurine; Mesna; Methotrexate; Hydrocortisone; Thiotepa; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Sulfhydryl Compounds; Sulfur Compounds; Purines; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Aminopterin; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Julio C. Barredo, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 1, 2004
• Study Start: January 1, 1996
• Primary Completion: June 1, 2004
• Last Updated: February 1, 2013

Record last verified: 2007-11

Locations

PR (1); CH (2); US (62); CA (5)