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iCAT for Recurrent/Refractory/HR Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853345
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Katherine Janeway, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date April 25, 2013
First Posted Date May 15, 2013
Last Update Posted Date February 10, 2015
Study Start Date August 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2013)
Frequency of a cancer causing actionable alteration and individualized treatment recommendation. [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title iCAT for Recurrent/Refractory/HR Solid Tumors
Official Title Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 99 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood samples, tumor samples
Sampling Method Non-Probability Sample
Study Population Pediatric patients with recurrent, refractory or high risk solid tumors
Condition
  • Pediatric Solid Tumor
  • Sarcoma
  • Neuroblastoma
  • Wilms Tumor
Intervention Not Provided
Study Groups/Cohorts Refractory/Recurrent/High Risk Solid Tumors
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2015)
101
Original Estimated Enrollment
 (submitted: May 10, 2013)
100
Study Completion Date Not Provided
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01853345
Other Study ID Numbers 11-406
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Katherine Janeway, MD, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators Not Provided
Investigators
Principal Investigator: Katherine Janeway, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date February 2015