Search / Trial NCT00002704

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 30, 2004

Trial Information

Current as of November 03, 2024

Completed

Keywords

Recurrent Childhood Acute Lymphoblastic Leukemia T Cell Childhood Acute Lymphoblastic Leukemia B Cell Childhood Acute Lymphoblastic Leukemia Td T Positive Childhood Acute Lymphoblastic Leukemia

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 ...

Gender

ALL

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

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Houston, Texas, United States

New York, New York, United States

Buffalo, New York, United States

Birmingham, Alabama, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Baltimore, Maryland, United States

Worcester, Massachusetts, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

Rochester, New York, United States

Stony Brook, New York, United States

Durham, North Carolina, United States

Winston Salem, North Carolina, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Charlottesville, Virginia, United States

Sacramento, California, United States

Gainesville, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Asheville, North Carolina, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Oklahoma City, Oklahoma, United States

Providence, Rhode Island, United States

Dallas, Texas, United States

Lackland Air Force Base, Texas, United States

San Antonio, Texas, United States

Milwaukee, Wisconsin, United States

Montreal, Quebec, Canada

Montreal, Quebec, Canada

San Juan, , Puerto Rico

Geneva, , Switzerland

La Jolla, California, United States

Baltimore, Maryland, United States

Syracuse, New York, United States

Hackensack, New Jersey, United States

New Haven, Connecticut, United States

New Orleans, Louisiana, United States

Edmonton, , Canada

Boston, Massachusetts, United States

Mobile, Alabama, United States

New Orleans, Louisiana, United States

Portland, Oregon, United States

Portsmouth, Virginia, United States

Richmond, Virginia, United States

Boston, Massachusetts, United States

Little Rock, Arkansas, United States

Kansas City, Kansas, United States

Hackensack, New Jersey, United States

Miami, Florida, United States

Wichita, Kansas, United States

Saint Louis, Missouri, United States

New Hyde Park, New York, United States

Charlotte, North Carolina, United States

Philadelphia, Pennsylvania, United States

Greenville, South Carolina, United States

Morgantown, West Virginia, United States

Toronto, Ontario, Canada

Bern, , Switzerland

Palo Alto, California, United States

Memphis, Tennessee, United States

San Diego, California, United States

Chicago, Illinois, United States

San Antonio, Texas, United States

Hamilton, Ontario, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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