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The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study

This study is currently recruiting participants.
Verified May 2017 by Katherine Janeway, MD, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02520713
First Posted: August 13, 2015
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Katherine Janeway, MD, Dana-Farber Cancer Institute
  Purpose
This research study is evaluating the use of specialized testing of solid tumors including sequencing. The process of performing these specialized tests is called tumor profiling. The tumor profiling may result in identifying changes in genes of the tumor that indicate that a particular therapy may have activity. This is called an individualized cancer therapy (iCat) recommendation. The results of the tumor profiling and, if applicable, the iCat recommendation will be returned.

Condition Intervention
Pediatric Solid Tumor Genetic: Genetic testing and GAIN report

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicenter Cohort Study To Evaluate Outcomes After Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults With Solid Tumors: The iCat2, GAIN Consortium Study

Resource links provided by NLM:


Further study details as provided by Katherine Janeway, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Identification of the patient, clinical, and medication access factors associated with a) having an iCat recommendation and b) with receipt of matched targeted therapy. [ Time Frame: 2 Years ]
  • Determination of factors associated with response and progression-free survival time by treatment group for patients with recurrent/refractory disease and measurable/evaluable disease. [ Time Frame: 2 Years ]
  • Description of the frequency and range of molecular alterations in pediatric solid tumors at diagnosis and at relapse including a comparison of potentially targetable variants in paired tumor samples obtained from relapse and at initial diagnosis. [ Time Frame: 2 Years ]
  • Determination of whether participation in a genomics study provides psychological well-being and whether that is associated with level of genomic comprehension and with receipt of an iCat recommendation. [ Time Frame: 2 Years ]

Estimated Enrollment: 825
Study Start Date: October 2015
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Genetic testing and GAIN report
All enrolled patients will submit specimens for sequencing and analysis.
Genetic: Genetic testing and GAIN report
All patients enrolled will submit specimens for genetic analysis. If successful the report will be reviewed to look for possible recommendations and a GAIN report will be generated regardless of possible recommendations.

Detailed Description:

Patients with extra-cranial (not in the brain) solid tumors that are either difficult to diagnose or more difficult to treat are eligible to participate in this study. All enrolled patients will have targeted sequencing of tumor performed. Sequencing results will be reviewed for clinically significant findings including determination of whether any mutations exist that suggest potential for activity of a targeted therapy (iCat recommendation). Results will be returned to the patient's oncologist and follow-up data will be collected.

In this prospective multi-center cohort study, the primary objective is to describe the outcomes of pediatric patients with advanced solid tumors according to whether or not they received of targeted therapy matched to an iCat recommendation. The primary clinical outcome of interest is the endpoint of overall survival (OS), with progression-free survival and response rate (RR) as key secondary clinical outcome measures. To address this hypothesis, 825 patients will enroll from an anticipated 11 participating institutions over 3 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age

    -- Age ≤ 30 years at time of initial qualifying solid tumor diagnosis

  • Diagnosis

    • Histologic diagnosis of solid malignancy (excluding brain tumors and lymphoma) that meets at least one of the following criteria:
    • Refractory, defined as tumor progression after initiation of standard first line therapy without having achieved a prior partial or complete remission OR Biopsy proven residual disease at the completion of planned standard initial front-line therapy.
    • Recurrent, defined as tumor progression after achieving a prior partial or complete remission
    • Newly diagnosed high risk disease, defined as having an expected event free survival of < 50% at 2 years.
    • Lacks definitive diagnosis or classical genomic findings after histologic review and standard molecular testing (rare tumor group).
  • Examples include (eligibility not limited to these examples):
  • Histology typically associated with a fusion in which fusion is not detected.
  • Ewing-like sarcoma
  • Undifferentiated sarcoma
  • Inflammatory myofibroblastic tumor without ALK fusion
  • Infantile fibrosarcoma without NTRK fusion
  • Specimen Samples

    • Sufficient tumor specimen available to meet the minimum requirements for profiling from diagnosis or progression / recurrence

      --- OR

    • Surgery / biopsy planned as part of clinical care that is anticipated to yield sufficient material to meet the minimum requirements for profiling;

Exclusion Criteria:

- No Therapy Planned

  • Patients who have declined further anticancer therapy will be excluded.

    - Performance Status

  • Patients with Lansky (age < 16 years) or Karnofsky (age ≥16 years) score < 50 will be excluded.

    - Life Expectancy

  • Patients with anticipated life expectancy < 3 months will be excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520713


Contacts
Contact: Katherine Janeway, MD 617-632-4994 KJANEWAY@PARTNERS.ORG

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Amit Sabnis, MD    415-476-3831    Amit.Sabnis@ucsf.edu   
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Margaret Macy, MD    720-777-6772    margaret.macy@childrenscolorado.org   
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, D.C., District of Columbia, United States, 20010
United States, Illinois
University of Chicago Comer Children's Hospital Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Katherine Janeway, MD    617-632-4994    kjaneway@partners.org   
Principal Investigator: Katherine Janeway, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Katherine Janeway, MD    617-632-4994    kjaneway@partners.org   
United States, New York
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Susan Vear, MD    614-722-2495    Susan.Vear@nationwidechildrens.org   
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Theodore Laetsch, MD    214-456-6405    ted.laetsch@utsouthwestern.edu   
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Navin Pinto, MD    206-987-2106    navin.pinto@seattlechildrens.org   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Katherine Janeway, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Katherine Janeway, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02520713     History of Changes
Other Study ID Numbers: 15-169
First Submitted: June 18, 2015
First Posted: August 13, 2015
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Katherine Janeway, MD, Dana-Farber Cancer Institute:
Pediatric Solid Tumor