iCAT for Recurrent/Refractory/HR Solid Tumors - Full Text View

Purpose

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
Pediatric Solid Tumor Sarcoma Neuroblastoma Wilms Tumor


Study Type:	Observational [Patient Registry]
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Neuroblastoma Wilms' Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Katherine Janeway, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:

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

Biospecimen Retention: Samples With DNA

Blood samples, tumor samples


Enrollment:	101
Study Start Date:	August 2012
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Refractory/Recurrent/High Risk Solid Tumors

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853345

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

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
Study First Received:	April 25, 2013
Last Updated:	February 9, 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

ClinicalTrials.gov processed this record on August 17, 2017