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Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors

30 Years
Open (Enrolling)
Pediatric Solid Tumor, Sarcoma, Neuroblastoma, Wilms Tumor

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Trial Information

Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors

Some cancer-causing gene alterations (such as mutations or copy number alterations) are
common or occur repeatedly in different types of cancers. For some of these alterations
there are drugs, called targeted drugs that specifically counteract the alteration. In
certain cancer types, these targeted drugs are very effective at fighting the cancer.

A tumor specimen that has been obtained previously or is planned to be obtained as part of
clinical care will be used to perform tumor profiling. Additional procedures to obtain tumor
will not be performed. An expert panel will review the results of the tumor profiling tests
and determine whether a cancer-causing alteration is present and whether an individualized
treatment recommendation can be made. If consent to sharing of the tumor profiling results
and individualized treatment recommendation is provided then a study physician will discuss
the profiling results and the individualized treatment recommendation with the primary
oncologist. In addition, the primary oncologist will receive a letter detailing the tumor
profiling results and the individualized treatment recommendation.

Inclusion Criteria:

- Diagnosis of recurrent, refractory of high risk pediatric solid tumor (excluding
brain tumor)

- Histologic proof of malignancy at the time of diagnosis or recurrence

- Sufficient tumor specimen available for profiling from diagnosis or recurrence, or
surgery/biopsy planned for clinical care

Exclusion Criteria:

- Brain tumors

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Frequency of a cancer causing actionable alteration and individualized treatment recommendation.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Katherine Janeway, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Pediatric Solid Tumor
  • Sarcoma
  • Neuroblastoma
  • Wilms Tumor
  • Refractory
  • Recurrent
  • High Risk
  • Wilms Tumor
  • Neuroblastoma
  • Neoplasms
  • Sarcoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Children's National Medical Center Washington, District of Columbia  20010-2970
Columbia University New York, New York  10032-3784
University of California, San Francisco San Francisco, California  94143
Boston Children's Hospital Boston, Massachusetts  02115