Clinical trial NCT01626170: Studying Mechanisms of Radiation Therapy Resistance in Samples From Younger Patients With Rhabdomyosarcoma
Official title: Observational - Identifying and Validating Novel Mechanisms of Radiation Resistance in Rhabdomyosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-22
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rhabdomyosarcoma enrolled on COG-D9902.

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

Detailed description: Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples with DNA Biospecimen Description: Tissue Study Population Description: Primary care clinic Sampling Method: Non-probability sample

OBJECTIVES:

I. Determine the molecular response/resistance signatures with radiotherapy and standard chemoradiation treatments using the xenograft model of the Pediatric Preclinical Testing Program (PPTP).

II. 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 criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Molecular response
timeFrame: Up to 1 year
measure: Novel pathway/biomarkers detected within clinically annotated patient tumor tissue samples
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Christopher Pelloski, MD
role: PRINCIPAL_INVESTIGATOR
References: