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

Advanced Cancers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00851032
• Other study ID #: 2007-0885
• Secondary ID: 1UL1RR024148
• Status: Recruiting
• Start date: February 2009
• Est. completion date: February 2021

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: Apostolia M. Tsimberidou, MD, PhD
• Phone: 713-792-4259
• Email: atsimber[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1) 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).

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

Intervention

Other:
• Molecular Profiling Analyses
Molecular profiling analyses from advanced cancer participants' stored tissue bank samples.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a program for the molecular profiling of patients with advanced cancer.	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.	6 Years

External Links

•   University of Texas MD Anderson Cancer Center Website