Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
MD and Razelle Kurzrock Jason Sicklick

Description

Summary

The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information from the patient's medical record regarding the tests and treatments they have received, or will receive, for their cancer will be collected. Genomic testing on tissue from the primary tumor or metastases will be used to match therapy recommendations. Patients in which there is no appropriate matched therapy will receive systemic chemotherapy according to their treating physician's discretion. This information will be used to describe whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor.

Official Title

An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Malignancies and Poor Prognosis

Details

This is a prospective, open label navigational investigation to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with incurable malignancies. This is a non-randomized, histology-agnostic trial. While it is known that individual histologies are composed of a heterogeneous mix of genomic alterations, it is not clear that one case mix is better or worse than another. Thus, a strategy of molecular matching that may apply across cancers is being tested. All eligible and consented patients will have their tumor tissues genomic profiled by Foundation Medicine's FoundationOne genomic analysis. Patients will be stratified into Group 1 (treatment naïve, unresectable/medically unfit for surgery), Group 2 (treatment naïve, metastatic), and Group 3 (prior treated), respectively. Following analysis for genomic alterations, matched therapy, if available, will be recommended by the Study Committee or Molecular Tumor Board. If the patients received the matched therapy, they are designated as in Arm A. Otherwise, if the patients received the unmatched therapy (i.e., treating physician's choice of traditional systemic chemotherapy), they are designated as in Arm B. The study feasibility will be measured by the ability to enroll patients, the acceptable turnaround time and the actionable information obtained from the genomic profiling, and the viability of identifying and delivering the matched therapy. The treatment efficacy will be determined among the patients groups and treatment arms. The safety profile of the treatment will also be assessed.

Keywords

Cancer

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with incurable malignancies with ≥50% 2-year cancer-associated mortality (as estimated by 2 physicians and where appropriate according to 2014 National Cancer Database).
  • Patients must have at least one of the following for diagnosis/disease status:
  • Unresectable disease
  • Metastatic disease
  • Medically unfit for surgical resection but with an expected survival of >3 months
  • Disease where no conventional therapy leads to a survival benefit >6 months
  • Actionable alterations determined by FoundationOne assay
  • For Groups 1 or 2, treatment naïve for newly diagnosed malignancies; patients must not have been treated with anti-tumor agents.
  • For Group 3, ≥1 prior unmatched systemic therapy regimens (no prior matched therapy is permitted as immediately prior therapy). Patients must be off other anti-tumor agents for at least 5 half-lives of the agent or 4 weeks from the last day of treatment,whichever is shorter.
  • Patients must have measurable disease for solid tumors.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1.
  • New York Hearth Association (NYHA) Functional Classification I - II.
  • Adequate organ and marrow function.

You CAN'T join if...

  • Disagreement of two oncologists on prognosis or resectability.
  • Severe or uncontrolled medical disorder that would, in the investigator's opinion,confound study analyses of treatment response.

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Avera Cancer Institute accepting new patients
    Sioux Falls South Dakota United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02534675
Study Type
Observational
Last Updated