Study on Autophagy Maintenance Therapy for Ovarian Cancer Patients
Sponsor: Medical University of South Carolina
ClinicalTrials ID:NCT06971744
This clinical trial is testing whether a combination of two drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV), along with the standard treatment bevacizumab, can help maintain health in ovarian cancer patients who have responded to previous treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to see if adding two drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV), to the standard maintenance treatment with bevacizumab can benefit patients with ovarian cancer. This study is for patients whose cancer has responded to platinum-based chemotherapy and who are in a maintenance phase to keep the cancer from returning.
Eligibility Criteria
Inclusion Criteria
- Have ovarian, fallopian tube, or primary peritoneal cancer that has responded to platinum-based chemotherapy and has not progressed for at least 6 months.
- Have undergone genetic testing to know BRCA mutation status or similar tests.
- Enroll in the study within 3-8 weeks after the last cycle of platinum-based chemotherapy.
- Have received at least 3 doses of bevacizumab during chemotherapy and plan to continue it.
- Show a positive response to current platinum-based chemotherapy.
- Be 18 years or older.
- Have a performance status score of 0 to 2, indicating good overall health.
- Have specific blood test results within normal limits.
- Agree to use effective birth control during the study and for 6 months after.
- Have stable blood pressure and diabetes if applicable.
- Be able to stop taking statins 48 hours before starting the study.
- Have a normal heart rhythm as shown by an ECG.
- Sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Have severe heart disease or recent heart attack.
- Have a serious mental health condition requiring hospitalization in the last two years.
- Have a significant neurological disorder.
- Have cancer that is resistant to platinum-based treatments.
- Have an active, uncontrolled infection.
- Have had recent radiation, surgery, or experimental treatment within 28 days before starting the study.
- Be unable or unwilling to follow study procedures.
- Be taking certain medications that cannot be stopped.
- Be pregnant or planning to become pregnant during the study.
- Have certain medical conditions like myasthenia gravis or G6PD deficiency.
- Be participating in another clinical trial.
- Have a high cardiovascular risk that requires continued statin use.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Medical University of South Carolina | 29425 | Charleston | South Carolina |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
