Safety and Pharmacokinetics of Treating Liver Cancer With Drug-Eluting Beads
Status:
Terminated
Trial end date:
2011-03-28
Target enrollment:
Participant gender:
Summary
Background:
- Cancers in other parts of the body often spread to the liver, developing tumors which in
many instances cannot be removed with surgery. Liver chemoembolization is a treatment
that is routinely performed to control liver tumors in those who cannot have surgery. It
has been shown to prolong survival, but does not cure the cancer. During
chemoembolization very tiny beads (drug-eluting beads, or DEB) containing chemotherapy
drugs (usually doxorubicin) are administered directly into the blood vessels of a liver
tumor. The drug within the beads is then released into the tumor whilethe beads
temporarily interrupt the tumor s blood supply.
- Irinotecan, a drug commonly given intravenously to treat colon cancer, has been given in
chemoembolization procedures in four other studies that have shown that the treatment is
generally well tolerated. Researchers are interested in determining whether giving the
drug irinotecan directly into the liver using drug-eluting beads is not only well
tolerated but also provides a larger dose directly to the tumor as determined by tumor
and normal liver tissue biopsies. The liver biopsies are an optional portion of the
study.
Objectives:
- To evaluate the safety and effectiveness of chemoembolization with irinotecan for tumors
caused by cancer that has spread to the liver.
Eligibility:
- Individuals at least 18 years of age who have melanoma, colon, or another intra-abdominal
cancer that has spread to the liver.
Design:
- Participants will be screened with a physical examination, medical history, blood tests,
tumor imaging studies, and liver biopsies.
- Participants will receive up to 3 DEB chemoembolization treatments about 6 weeks apart.
- After two treatments, participants will have imaging studies to see if the tumors have
shrunk, and those whose tumors have shrunk may have a third treatment.
- Multiple liver biopsies may be performed and blood samples will be taken to determine
how much drug is in the tumor and the circulation, and to see how the tumor reacts to
the drug.
- Participants will return for followup visits for up to 1 year....
Phase:
Phase 1
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)