National Cancer Institute (NCI) is recruiting patients for a PHASE1 clinical trial testing HIPEC (heated intraperitoneal chemotherapy) for mesothelioma.
The trial, designated NCT04847063, aims to enroll up to 60 participants at 1 sites, including locations in Maryland.
About the Study
Background:
Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy drugs used in HIPEC.
Objective:
To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System.
Eligibility:
Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Computed tomography (CAT) scan
Other imaging scans, as needed
Electrocardiogram (EKG)
Tumor biopsy, if needed
Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera will be used to see their organs.
Some screening tests will be repeated in the study.
Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research.
Participants will have CRS. As many of their visible tumors will be removed as possible. They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get chemotherapy through one tube. It will be drained out through the other tube. They will be in the hospital for 7-21 days after surgery.
Participants will give tumor, blood, and fluid samples for research. They will complete surveys about their health and quality of life.
Participants will have follow-up visits over 5 years.
Treatment Approach
This trial uses heated chemotherapy delivered directly into the abdominal cavity during surgery.
Key trial details:
- Phase: PHASE1
- Sponsor: National Cancer Institute (NCI)
- Enrollment target: 60
- Status: RECRUITING
Why This Trial Matters
HIPEC has shown promise for peritoneal mesothelioma, with some patients achieving long-term survival when combined with cytoreductive surgery. This trial is sponsored by the National Cancer Institute, signaling significant federal investment in mesothelioma research.
Study Locations
The trial is recruiting at:
- National Institutes of Health Clinical Center, Maryland
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening