iCAT for Recurrent/Refractory/HR Solid Tumors

• ClinicalTrials.gov Identifier: NCT01853345
• Recruitment Status: Completed
• First Posted: May 15, 2013
• Last Update Posted: February 10, 2015
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Katherine Janeway, MD, Dana-Farber Cancer Institute

Study Description

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

• 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

Group/Cohort
Refractory/Recurrent/High Risk Solid Tumors

Outcome Measures

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

• 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

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

Additional 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 CWM, 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 May 1;2(5):608-615. doi: 10.1001/jamaoncol.2015.5689.

• Responsible Party: Katherine Janeway, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT01853345
• 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; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; 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