ClinicalTrials.gov
ClinicalTrials.gov Menu

Genomic Profiling in Recommending Treatment for Patients With Metastatic 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: NCT02215928
Recruitment Status : Unknown
Verified April 2016 by Stanford University.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : April 20, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This research trial studies using genomic profiling to recommend anticancer treatment to patients with cancer that has spread beyond the original site of the tumor (metastatic cancer). Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. This information can then be used to recommend treatments that may be more likely to result in a beneficial response. It is not yet known whether genomic profiling will detect abnormalities that can be used to make treatment recommendations and whether treatment based on genomic profiling is more effective than standard treatment.

Condition or disease Intervention/treatment
Unspecified Adult Solid Tumor, Protocol Specific Genetic: mutation analysis Other: cytology specimen collection procedure Other: laboratory biomarker analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. Assess the feasibility of integrating tumor genomic profiling in the adult oncology clinic at the Stanford Cancer Institute.

SECONDARY OBJECTIVES:

I. Determine the percentage of tumors that harbor "actionable" genomic changes. II. Explore effects of individual molecular profiling including the percent of time that profiling changes the treatment.

III. Determine the number of cases in which a genomically identified targeted therapy is available.

IV. Determine the clinical benefit of genomic based therapy, as defined by: response rate (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 response criteria); the percent of patients with non-progression at 4 months, and overall survival, in patients whose therapy is selected based on profiling.

V. Determine if circulating free tumor DNA (ctDNA) in the blood stream (liquid biopsy) yields similar genomic results as the metastatic tumor analysis.

VI. Determine if ctDNA analysis during treatment correlates with RECIST 1.1 criteria in predicting response.

OUTLINE:

Tissue samples are collected at baseline and blood for liquid biopsy is collected at baseline and every 6-8 weeks during active treatment. Tissue samples are analyzed via sequencing for tumor genomic profiling.

After completion of active treatment, participants are followed up at 4, 8, 12, 18, and 24 months.


Study Type : Observational
Estimated Enrollment : 100 participants
Official Title: Tumor Genomic Profiling: A Personalized Medicine Approach
Study Start Date : July 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Group/Cohort Intervention/treatment
Ancillary-correlative (tumor genomic profiling)
Tissue samples are collected at baseline and blood for liquid biopsy is collected at baseline and every 6-8 weeks during active treatment. Tissue samples are analyzed via sequencing for tumor genomic profiling.
Genetic: mutation analysis
Correlative studies

Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Feasibility, measured as the proportion of patients with at least one actionable alteration [ Time Frame: Baseline ]
    An actionable alteration is defined as availability of targeted therapy, scored as: A) an FDA-approved drug, B) an FDA-approved drug in another tumor type, or C) a drug that is not yet approved but has a clinical trial open. The percentage of patients in the "profile" arm with successful profiling will be calculated and further characterized by availability category.


Secondary Outcome Measures :
  1. Drugs (if any) that target alterations found in a patient's tumor material at baseline, as identified by the Molecular Tumor Board [ Time Frame: Baseline ]
  2. Drugs (if any) that target alterations found in a patient's peripheral blood at baseline, as identified by the Molecular Tumor Board [ Time Frame: Baseline ]
  3. Availability of targeted therapy from tumor material scored as category A, B, or C above or D) No target therapy available, or no genetic alterations found [ Time Frame: Baseline ]
  4. Overall survival [ Time Frame: Number of days from enrollment to death, assessed up to 24 months ]
    Overall survival of patients in each cohort will be characterized using Kaplan-Meier plots and the two cohorts will be compared using a Cox model to control for age and sex.

  5. Clinical response rate, assessed according to RECIST 1.1 criteria [ Time Frame: Up to 24 months ]
    Response will be compared using logistic regression, adjusting for the same risk factors.

  6. Incidence of adverse events [ Time Frame: Up to 30 days after last dose of active treatment ]
    Categorized by grade and MedDRA preferred term.

  7. Tumor-based genomics [ Time Frame: Baseline ]
    Comparison of tumor-based genomics with peripheral-blood genomics will be carried out by comparing the list of genetic aberrations found in the two different samples (tumor vs ctDNA) and possible target drugs identified from each source. Agreement on success of profiling will be assessed using a kappa statistic.

  8. Peripheral-blood genomics [ Time Frame: Baseline ]
    Comparison of tumor-based genomics with peripheral-blood genomics will be carried out by comparing the list of genetic aberrations found in the two different samples (tumor vs ctDNA) and possible target drugs identified from each source. Agreement on success of profiling will be assessed using a kappa statistic.


Biospecimen Retention:   Samples With DNA
liquid biopsy


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult oncology clinic at the Stanford Cancer Institute
Criteria

Inclusion Criteria:

  • Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
  • Have a diagnosis of metastatic, incurable cancer and have progressed on at least one line of systemic therapy OR a cancer with no standard 1st-line systemic therapy shown to prolong survival (or where a clinical trial recommended as the 1st-line option)
  • Measurable disease (RECIST 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • In the opinion of the investigator, be medically suitable for and willing to undergo a biopsy or surgical procedure to obtain tissue as a part of routine care for their malignancy OR have adequate archival tissue from a previous biopsy available for profiling
  • Female patients of childbearing potential must have a negative pregnancy test and agree to use at least one form of contraception during the study and for at least one month after treatment discontinuation; for the purposes of this study, child-bearing potential is defined as: all female patients that were not in post-menopause for at least one year or are surgically sterile
  • Male patients must use a form of barrier contraception approved by the investigator/treating physician during the study and for at least one month after treatment discontinuation

Exclusion Criteria:

  • Have lesions that are not accessible to biopsy or not planned for biopsy as part of routine care OR if archival tissue will be used for profiling, an insufficient amount is available
  • Have diagnosis of a hematologic malignancy
  • Have symptomatic central nervous system (CNS) metastasis; patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for >= 2 weeks prior to enrollment
  • Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
  • Have known human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) infection
  • Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215928


Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Meredith Mills    650-724-5223    bluett@stanford.edu   
Principal Investigator: James M. Ford         
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Ford Stanford University Hospitals and Clinics

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02215928     History of Changes
Other Study ID Numbers: VAR0114
NCI-2014-01662 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VAR0114 ( Other Identifier: Stanford University Hospitals and Clinics )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016