iCAT for Recurrent/Refractory/HR Solid Tumors

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Pediatric Solid Tumor; Sarcoma; Neuroblastoma; Wilms Tumor

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.

Study Design

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Study Type :	Observational [Patient Registry]
Actual Enrollment :	101 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	99 Years
Official Title:	Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors
Study Start Date :	August 2012
Actual Primary Completion Date :	September 2014

Groups and Cohorts

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Group/Cohort
Refractory/Recurrent/High Risk Solid Tumors

Outcome Measures

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Primary Outcome Measures :

1. Frequency of a cancer causing actionable alteration and individualized treatment recommendation. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA

Blood samples, tumor samples

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 30 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pediatric patients with recurrent, refractory or high risk solid tumors

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National Medical center
Washington, District of Columbia, United States, 20010
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

Principal Investigator:	Katherine Janeway, MD	Dana-Farber Cancer Institute

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harris MH, DuBois SG, Glade Bender JL, Kim A, Crompton BD, Parker E, Dumont IP, Hong AL, Guo D, Church A, Stegmaier K, Roberts CW, Shusterman S, London WB, MacConaill LE, Lindeman NI, Diller L, Rodriguez-Galindo C, Janeway KA. Multicenter Feasibility Study of Tumor Molecular Profiling to Inform Therapeutic Decisions in Advanced Pediatric Solid Tumors: The Individualized Cancer Therapy (iCat) Study. JAMA Oncol. 2016 Jan 28. doi: 10.1001/jamaoncol.2015.5689. [Epub ahead of print]

Responsible Party:	Katherine Janeway, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT01853345 History of Changes
Other Study ID Numbers:	11-406
First Posted:	May 15, 2013
Last Update Posted:	February 10, 2015
Last Verified:	February 2015

Keywords provided by Katherine Janeway, MD, Dana-Farber Cancer Institute:

Refractory; Recurrent; High Risk

Additional relevant MeSH terms:

Neoplasms; Neuroblastoma; Wilms Tumor; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial	Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn