iCAT for Recurrent/Refractory/HR Solid Tumors

Completed

• Conditions: Wilms Tumor; Sarcoma; Neuroblastoma; Pediatric Solid Tumor

• Registration Number: NCT01853345
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

In this study tumor will be tested for cancer causing gene alterations such as mutations or copy number alterations. This is called tumor profiling. A panel of experts will review the tumor profiling results and determine whether there is a cancer-causing alteration present in the tumor. If there is, the experts will determine if there is a targeted drug available that could counteract this alteration. If there is an alteration identified and a targeted drug available the panel of experts will make an individualized treatment recommendation. The results of the tumor profiling and the individualized treatment recommendation can be shared with the primary oncologist.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Primary Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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Exclusion Criteria

• Brain tumors

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of a cancer causing actionable alteration and individualized treatment recommendation.	2 years

Trial Locations

Locations (5)

Children's National Medical center; 🇺🇸 Washington, District of Columbia, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States