Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors

Launched by STANFORD UNIVERSITY · Aug 11, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating a method called genomic profiling to help doctors choose the best cancer treatments for patients whose cancer has spread beyond the original tumor site, known as metastatic cancer. Genomic profiling looks at the DNA of the tumor to find any genetic changes that might inform treatment decisions. The goal is to see if this approach can identify better treatment options compared to the standard therapies currently available.

To participate in this trial, patients need to have an incurable metastatic cancer and have tried at least one previous treatment that hasn’t worked. They should be able to provide consent and have a measurable disease, meaning that their cancer can be tracked through medical imaging. Additionally, patients must be willing to undergo a biopsy, which is a procedure to collect tissue from the tumor. The trial is open to adults aged 18 and older, and it is important for female participants to be on contraception if they have childbearing potential. Overall, participants will undergo tests and procedures to guide their treatment options, but it is important to note that the effectiveness of genomic profiling compared to standard treatments is still being studied.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
• • Have a diagnosis of metastatic, incurable cancer and have progressed on at least one line of systemic therapy OR a cancer with no standard 1st-line systemic therapy shown to prolong survival (or where a clinical trial recommended as the 1st-line option)
• • Measurable disease (RECIST 1.1)
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• • In the opinion of the investigator, be medically suitable for and willing to undergo a biopsy or surgical procedure to obtain tissue as a part of routine care for their malignancy OR have adequate archival tissue from a previous biopsy available for profiling
• • Female patients of childbearing potential must have a negative pregnancy test and agree to use at least one form of contraception during the study and for at least one month after treatment discontinuation; for the purposes of this study, child-bearing potential is defined as: all female patients that were not in post-menopause for at least one year or are surgically sterile
• • Male patients must use a form of barrier contraception approved by the investigator/treating physician during the study and for at least one month after treatment discontinuation
• Exclusion Criteria:
• • Have lesions that are not accessible to biopsy or not planned for biopsy as part of routine care OR if archival tissue will be used for profiling, an insufficient amount is available
• • Have diagnosis of a hematologic malignancy
• • Have symptomatic central nervous system (CNS) metastasis; patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for \>= 2 weeks prior to enrollment
• • Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
• • Have known human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) infection
• • Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception