Clinical trial NCT00851032: Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial, An Umbrella Protocol
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Cancers
Keywords: Advanced Cancer
Initiative for Molecular Profiling in Advanced Cancer Therapy
IMPACT
Molecular Profile-Based Study
Investigational Cancer Therapeutics Program
Molecular profiling
Phase I Therapies
Tissue Bank
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2009-02-25
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Advanced Cancer Treated in the Investigational Cancer Therapeutics Program Registered on MDACC tissue bank protocol (LAB07-0817).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Establish a program for the molecular profiling of patients with advanced cancer.
timeFrame: 6 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Apostolia M. Tsimberidou, MD, PHD
role: STUDY_CHAIR
References:
citation: Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, Janku F, Naing A, Fu S, Piha-Paul S, Cartwright C, Broaddus RR, Nogueras Gonzalez GM, Hwu P, Kurzrock R. Long-term overall survival and prognostic score predicting survival: the IMPACT study in precision medicine. J Hematol Oncol. 2019 Dec 30;12(1):145. doi: 10.1186/s13045-019-0835-1.