NCT01853345

iCAT for Recurrent/Refractory/HR Solid Tumors

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Solid Tumor
• Sarcoma
• Neuroblastoma
• Wilms Tumor

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-09-01
• First posted: 2013-05-15
• Last updated: 2015-02-10

Locations

5 sites across 1 country: United States