Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial, An Umbrella Protocol
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.
- To characterize advanced cancer by delineating genetic mutations, amplifications, translocations, and other defining molecular patient characteristics.
- 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.
- 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.
- 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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||An Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial. A Molecular Profile-Based Study in Patients With Advanced Cancer Treated in the Investigational Cancer Therapeutics Program|
- Establish a program for the molecular profiling of patients with advanced cancer. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]For characterizing the molecular profile, descriptive statistics and exploratory data analysis performed first. Categorical data described using contingency tables. Continuously scaled measures summarized with descriptive statistical measures (i.e., mean (± s.d.) and median (range)). Distribution plots such as histograms and box plots applied.
Biospecimen Retention: Samples With DNA
Specimen obtained from MDACC Tissue Bank.
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Molecular Profiling Analyses
Participants seen in the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center in Houston, Texas
Other: Molecular Profiling Analyses
Molecular profiling analyses from advanced cancer patients' stored tissue bank samples.
The prognosis of patients with advanced metastatic malignancies is poor, and their median survival, irrespective of diagnosis, is approximately 8.8 months (95% confidence interval, 7.4 to 10.9 months). In recent years there has been increased interest in novel agents.
Elucidating the molecular basis of advanced cancer will lead to the development of potentially curative strategies for these diseases aimed at the specific molecular and genetic aberrations characteristic of specific tumors.
This study is a molecular profiling analyses of the patients' stored samples and will not involve more than minimal risk to the subjects. Subjects are at no more than minimal risk because only leftover blood, tissue, and patient data will be used for this study, and all patient data will be kept confidential.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851032
|Contact: Apostolia M. Tsimberidou, MD, PhD||713-792-4259|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Apostolia Tsimberidou, MD, PhD|
|Study Chair:||Apostolia M. Tsimberidou, MD, PHD||M.D. Anderson Cancer Center|