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Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003793
First received: November 1, 1999
Last updated: November 20, 2010
Last verified: November 2010
History of Changes
  Purpose

RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.

PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.


Condition Intervention
Leukemia
Myelodysplastic Syndromes
Sarcoma
 Genetic: clonality analysis
Genetic: microsatellite instability analysis
Genetic: mutation analysis

Study Type: Observational
Official Title: Clinical and Biological Predictors of Therapy-Related Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 321
Study Start Date: December 1998
Detailed Description:

OBJECTIVES:

  • Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
  • Identify patients who are at increased risk of t-MDS/AML during or after therapy.

OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.

Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of sarcoma including:

    • Rhabdomyosarcoma
    • Ewing's sarcoma
    • Primitive neuroectodermal tumor
    • Fibrosarcoma
    • Malignant peripheral nerve sheath tumor
    • Synovial cell sarcoma
    • Osteosarcoma
    • Other soft tissue sarcoma
  • Must be currently receiving intensive or high-dose chemotherapy for sarcoma

PATIENT CHARACTERISTICS:

Age:

  • Children

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003793

  Show 96 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Stella M. Davies, MBBS, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003793     History of Changes
Other Study ID Numbers: CDR0000066936, COG-AB9804, CCG-B9804
Study First Received: November 1, 1999
Last Updated: November 20, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
localized osteosarcoma
metastatic osteosarcoma
childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
metastatic childhood soft tissue sarcoma
 childhood fibrosarcoma
childhood synovial sarcoma
childhood neurofibrosarcoma
previously untreated childhood rhabdomyosarcoma
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Rhabdomyosarcoma
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
 Precancerous Conditions
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 21, 2013