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

Age Range:Any - 30
Start Date:October 2015
End Date:July 2022
Contact:Katherine Janeway, MD

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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

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.

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.

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

- 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; OR

- Patient has already had molecular profiling and patient has not yet started
matched targeted therapy based on the report .

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
We found this trial at
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 206-987-2106
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
Seattle, WA
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5721 S. Maryland Avenue
Chicago, Illinois 60637
Chicago, IL
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-2495
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
Columbus, OH
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Phone: 214-456-6405
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
Dallas, TX
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-6772
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Aurora, CO
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Katherine Janeway, MD
Phone: 617-632-4994
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
Phone: 617-632-4994
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Boston, MA
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630 W 168th St
New York, New York
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
New York, NY
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Salt Lake City, Utah 84113
Salt Lake City, UT
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San Francisco, California 94143
Phone: 415-476-3831
San Francisco, CA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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