Study on Vismodegib for Treating Cancers with Specific Genetic Mutations
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06357988
This clinical trial is testing the effectiveness of the drug vismodegib in treating patients with advanced cancers that have specific genetic mutations. The study aims to see if this drug can help control cancer growth in patients whose cancer has spread or is not responding to other treatments.
Patient Parameters
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Program Overview
This study is exploring how well the drug vismodegib works in treating patients with advanced cancers, including solid tumors, lymphoma, or multiple myeloma, that have specific genetic mutations known as smoothened or patched 1. Vismodegib is a medication that targets a pathway involved in tissue growth and repair, potentially stopping cancer cells from growing. The trial is for patients whose cancer has spread or is not responding to other treatments.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer with the use of vismodegib. Researchers will also look at how many patients are alive and have no cancer progression after six months of treatment. They will study how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will explore other biological markers that might predict how well the treatment works or why it might not work.
Patients will take vismodegib by mouth every day in 28-day cycles, as long as the cancer does not progress and side effects are manageable. Throughout the study, patients will have heart tests, tumor biopsies, and imaging scans like CT or MRI, along with blood tests to monitor their health and the treatment's effects. After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for the third year.
Eligibility Criteria
Inclusion Criteria
- Must meet eligibility criteria from the main MATCH protocol before joining this treatment study.
- Must have specific genetic mutations in smoothened (SMO) or patched 1 (PTCH1) genes.
- Cannot have basal cell carcinoma.
- Must have a recent ECG with no serious heart rhythm issues.
- If there is known heart dysfunction, must have a recent heart function test showing normal results.
- Cannot be allergic to vismodegib or similar drugs.
- Women and men who are sexually active must use effective birth control methods during the study and for a specified time after completing the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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