Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01775072
First received: January 21, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether certain genes in cancer may be abnormal. When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not inherited (passed down from parents) but happen after birth in the cancer itself. Most cancers have many mutations. Some of these mutations are important for the cancer cells to survive while others are not. The goal of this study is test cancer for certain mutations using leftover tumor tissue from a previous surgery or biopsy. Participants will also be asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample that contains normal genes for comparison.

The purpose of Part B of this study is to:

Understand how genetic changes in tumor effect the chance of responding to experimental cancer treatment. Understand how the genes in the tumor change overtime in response to targeted cancer treatment.


Condition Intervention
Solid Tumors
Hematologic Cancers
Other: molecular profiling of tumors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • frequency of "actionable" oncogenic mutations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    "Actionable" mutations will be defined as either 1) a mutation shown to predict for sensitivity or resistance to a drug FDA approved for use in another cancer indication or 2) a mutation which predicts for sensitivity or resistance in preclinical models to an investigational class of drugs.


Secondary Outcome Measures:
  • To determine the impact of molecular profiling results performed in the CLIA-setting on the treatment of patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Bioinformatics Core will assist in interpreting data generated by next-generation sequencing techniques such as WES and WGS.

  • interrogate the mechanisms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    underlying response and resistance (de-novo and acquired) to targeted therapy. The research assay(s) used to accomplish this will vary based on the clinical setting and tissue available and may include Sanger, Sequenom, MiSeq, exon-capture (ie: IMPACT), whole exome, and whole genome sequencing.

  • To explore the genetic mechanisms of tumorigenesis [ Time Frame: 2 ] [ Designated as safety issue: No ]
    in a subset of specimens with no identifiable culpritic genomic alterations on highly-multiplexed next-generation sequencing (i.e.: IMPACT testing) by using even more comprehensive investigational profiling techniques such as whole exome sequencing, whole genome sequencing or RNA sequencing


Biospecimen Retention:   Samples With DNA

tissue blood saliva


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pts with solid tumors
Patients must have solid or hematologic cancer. for treatment on a . Patients must have undergone pathologic confirmation of their tumor at MSKCC and have either: 1) archival tissue available for analysis, 2) have fresh tissue collection planned as routine standard of care biopsy (or peripheral blood / bone marrow collection in the case of hematologic cancers)outside of the context of this protocol, or 3)archival tissue .available at an outside facility. For prospective genotyping tissue specimens from the primary site, a metastasis or recurrence will be used based upon the availability and quality of tissue.
Other: molecular profiling of tumors
Part A is the molecular profiling of tumors. No new tumor biopsies will be performed in the context of Part A. If a pt does have a surgery or tumor biopsy as routine standard of care, leftover tissue from this procedure may be used for molecular profiling. Clinical Assay(s): This testing will be performed in the CLIA-certified Molecular Diagnostics Service laboratory. Research Assay(s): This protocol will also be used as a platform to pilot the use of investigational "next-generation" profiling technologies .including whole exome sequencing, whole genome sequencing RNA sequencing cell-free tumor DNA sequencing, and others. To confirm the findings obtained on these assays using an orthogonal assay, additional sequencing such as Sanger,Sequenom, MiSeq or IMPACT testing may be utilized in either the CLIA or non-CLIA setting Part B: DTC Cohort Pts successfully registered to Part B of this study will be eligible for minimal risk collection & research biopsies.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with solid or hematologic cancers who may be and considered potential candidates for a therapeutic protocol will be recruited to Part A of this study. Enrollment to therapeutic clinical trials will not be contingent on enrollment in this protocol.

Part B: Research Collection Cohort Patients potentially appropriate will be identified by their treating physician in each participating Disease Management Team.

Criteria

Inclusion Criteria:

Part A:

  • Patients with solid or hematologic tumor.
  • There is Sufficient archival tissue for molecular profiling a plan to obtain fresh tumor tissue as routine standard of care and/or obtain from outside source.

Part B:

  • Patients successfully registered to Part A of (MSKCC IRB # 12-245)
  • Prior written approval for patient consent obtained from Director of the Center fo Molecular Oncology, or a Principal/Co-Principal Investigator of MSKCC IRB # 12-245.

Exclusion Criteria:

  • Unwilling or unable to provide informed consent.
  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: NCT01775072

Contacts
Contact: David Hyman, MD 646-888-4544
Contact: David Solit, MD 646-888-2641

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: David Hyman, MD    646-888-4544      
Contact: David Solit, MD    646-888-2641      
Principal Investigator: David Hyman, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: David Hyman, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01775072     History of Changes
Other Study ID Numbers: 12-245
Study First Received: January 21, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
tissue
blood
salvia
buccal swab
Genomic Profiling
Solid Tumors
hematologic cancer
Clinical Assay
Research Assay
12-245

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014