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Studying Mechanisms of Radiation Therapy Resistance in Samples From Younger Patients With Rhabdomyosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01626170
First received: June 20, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This laboratory study is looking into mechanisms of radiation therapy resistance in samples from younger patients with rhabdomyosarcoma.


Condition Intervention
Sarcoma
 Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymorphism analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Identifying and Validating Novel Mechanisms of Radiation Resistance in Rhabdomyosarcoma

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Molecular response/resistance signatures of radiotherapy and standard chemoradiation using Spearman's rho [ Designated as safety issue: No ]
  • Novel pathway/biomarkers associated with clinical response [ Designated as safety issue: No ]
  • Novel pathway/biomarkers associated with local control rates using log-rank and univariate/multivariate Cox regression analysis [ Designated as safety issue: No ]
  • Novel pathway/biomarkers associated with overall survival rates using log-rank and univariate/multivariate Cox regression analysis [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the molecular response/resistance signatures with radiotherapy and standard chemoradiation treatments using the xenograft model of the Pediatric Preclinical Testing Program (PPTP).
  • Validate these novel pathways/biomarkers by their detection within clinically annotated patient tumor tissue samples and testing their associations with clinical response, local control rates, and overall survival rates.

OUTLINE: Archived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Tissues requested from the Children Oncology Group (COG) sarcoma banking protocol COG-D9902

  • All subtypes of rhabdomyosarcoma specimens

    • Matched primary-relapsed specimens (from same patient, separated by time):

      • Frozen tissue if available
      • Scrolls of formalin-fixed paraffin-embedded tissue (if frozen not available)
      • 10 unstained formalin-fixed paraffin-embedded thin sections

    • All other general (primary or relapsed) cases

      • 10 unstained formalin-fixed paraffin-embedded thin sections

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626170

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christopher E. Pelloski, MD Ohio State University Comprehensive Cancer Center
  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

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01626170     History of Changes
Other Study ID Numbers: CDR0000735399, COG-ARST12B6
Study First Received: June 20, 2012
Last Updated: June 25, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
alveolar childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma

Additional relevant MeSH terms:
Rhabdomyosarcoma
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013