Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial, An Umbrella Protocol

Status unconfirmed

Conditions studied: Advanced Cancers

In brief

Primary Objective The primary objective of this study is to establish a program for the molecular profiling of patients with advanced cancer, with the goals of (1) providing a comprehensive characterization of the molecular profiles of individual patients and (2) correlating molecular profile with response to phase I therapies. Specimens will be received from the LAB07-0817 (Tissue Bank) protocol in the Department of Investigational Cancer Therapeutics. Note that this study is considered an umbrella protocol to systematically enroll phase I patients for molecular profiling analysis and correlate the results with treatment outcomes. The IMPACT trial is not a treatment protocol. Secondary Objectives 1. To characterize advanced cancer by delineating genetic mutations, amplifications, translocations, and other defining molecular patient characteristics. 2. To assess the antitumor effects of treatments by tumor responses using the World Health Organization (WHO) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria and/or any other clinical benefits, including progression-free survival and overall survival, demonstrated in phase I clinical trials. 3. To correlate molecular profiles of patients with evidence of antitumor activity (complete remission, partial remission, prolonged stable disease, or overall survival) to define subsets of patients who will respond to specific therapies in clinical trials of novel agents. 4. To correlate molecular profiles with toxicities induced by investigational agents to define subsets of patients who may or may not be candidates for treatment with these agents in the future.

Key facts

Study ID: NCT00851032
Run by: M.D. Anderson Cancer Center
People needed: 5000
Starts: 2009-02-01
Expected to finish: 2021-02-01
Last updated by the study team: 2019-05-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Any patient seen in the department of Investigational Cancer Therapeutics is eligible. Patients who have blood or tissue samples collected must be registered on the tissue bank protocol (LAB07-0817).

You may not qualify if…

Where it is running

University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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