Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

August 4, 2014 updated by: Children's Oncology Group

Clinical and Biological Predictors of Therapy-Related Leukemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

294

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Brisbane, Queensland, Australia, QLD 4029
        • Office of S. David Lang
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario At Kingston General Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
      • Ste-Foy, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • United States
    • California
      • Downey, California, United States, 90242
        • Southern California Permanente Medical Group
      • Long Beach, California, United States, 90806
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Madera, California, United States, 93638
        • Children's Hospital Central California
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
      • Stanford, California, United States, 94305
        • Stanford Comprehensive Cancer Center at Stanford University Medical Center
    • Connecticut
      • Farmington, Connecticut, United States, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, United States, 32610-0232
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, United States, 32207-8482
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Miami, Florida, United States, 33176-2197
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, United States, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Savannah, Georgia, United States, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital - Chicago
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Blank Children's Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40232
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital of New Orleans
    • Maine
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
      • Scarborough, Maine, United States, 04074
        • Maine Children's Cancer Program
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0286
        • C.S. Mott Children's Hospital at University of Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospital - Butterworth Campus
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center & Children's Hospital - Fairview
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Cancer Center
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, United States, 11220
        • Maimonides Cancer Center at Maimonides Medical Center
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • Stony Brook, New York, United States, 11794-8174
        • Stony Brook University Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • Children's Medical Center - Dayton
      • Youngstown, Ohio, United States, 44501
        • Tod Children's Hospital - Forum Health
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97227
        • Institute of Oncology at Vilnius University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19134-1095
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37901
        • East Tennessee Children's Hospital
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center - Fort Worth
      • Lubbock, Texas, United States, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, United States, 78229
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Virginia
      • Fairfax, Virginia, United States, 22042-3300
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Cancer Center at Sacred Heart Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children receiving high dose chemotherapy for sarcomas.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Identification of Genetical suceptibility prior to therapy
Determine the glutathione-s-transferase theta (GSTT1) or glutathione-s-transferase mu (GSTM1) null genotype is more frequent in individuals with t-MDS/AML. Determine the GSTT1 or GSTM1 null genotype is associated with a reduced incidence of relapse of sarcoma. Determine NAT2 or CYP1A1 genotype influences risk of t-MDS/AML. Determine development of a "mutator phenotype" as demonstrated by developing microsatellite instability is an early marker of individuals likely to progress to t-MDS/AML.
Genetic: mutation analysis
Genetic: microsatellite instability analysis
Increased Risk Of T-MDS/AML before/after Therapy
Determine clonal hematopoiesis develops in children receiving high intensity alkylating agent chemotherapy for sarcomas. Determine development of clonal hematopoiesis is associated with increased frequency of t-MDS/AML. Determine measurement of somatic cell mutation frequency, measured by the glycophorin A (GPA) assay prior to and after chemotherapy will predict individuals at increased risk of t-MDS/AML. Identify individuals with ras gene mutations in normal peripheral blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML.
Genetic: mutation analysis
Genetic: microsatellite instability analysis
Genetic: clonality analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Event Free Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Stella M. Davies, MBBS, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB9804
  • COG-AB9804 (Other Identifier: Children's Oncology Group)
  • CCG-B9804 (Other Identifier: Children's Cancer Group)
  • CDR0000066936 (Other Identifier: Clinical Trials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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