The iCat2, GAIN Consortium Study

Status: Recruiting
Phase: N/A
DFCI Protocol ID: 15-169

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.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Katherine Janeway, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility 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.

  -  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 demonstrating a potentially
  targetable variant in a laboratory certified to generate a clinical report, but
  the patient has not yet started therapy matched to the variant AND sufficient
  tumor specimen is available to meet the minimum requirement for profiling from
  the same procedure and tissue from which the prior testing was performed.

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.

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