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
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.
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.
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