Safety and Pharmacokinetics of Treating Liver Cancer With Drug-Eluting Beads

Melanoma Clinical Trial

Official title: Phase Ib Study of the Safety and Pharmacokinetics of Chemoembolization With Irinotecan-Eluting Beads for the Treatment of Hepatic Metastases

Status Terminated

Clinical Trial 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....

Clinical Trial Description

Background:

• Clinical evidence suggests that hepatic chemoembolization may prolong survival in patients with hepatic metastases.

• Early studies have indicated that chemoembolization using irinotecan drug eluting beads may be more effective in treating hepatic metastases from colon or melanoma primary tumors.

Objectives:

• Primary Objective:

--To determine the safety of hepatic chemoembolization with drug-eluting beads containing 100mg of irinotecan

• Secondary Objectives:

• To determine the serum pharmacokinetics and tumor tissue concentrations achieved following hepatic chemoembolization with irinotecan-eluting beads

Eligibility:

• Patients > 18 years of age with pathologically proven hepatic metastases from the gastrointestinal tract, or melanoma with unresectable hepatic lesions.

• Patients whose extent of hepatic metastases represents <60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal

• Patients must be ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months.

• Patients must have adequate organ function.

• Patients must not have had chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments.

• Patients are not to receive conventional chemotherapy or therapeutic monoclonal antibodies while on study.

• Patients must not have an acute, critical illness.

Design:

• A Phase Ib trial in which patients undergo hepatic chemoembolization with drug-eluting beads containing 100mg irinotecan.

• Up to 15 patients will be enrolled over 1 year to accrue 10 evaluable patients.

• Patients will undergo up to 3 chemoembolizations.

• Following chemoembolization, patients will have serial serum pharmacokinetic samples drawn and tumor biopsies in order to measure serum and tumor tissue concentrations of irinotecan

• Patients will be followed for one year after completion of the last treatment. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Melanoma
• Neoplasm Metastases
• Neoplasm Metastasis
• Neoplasms

• NCT number: NCT01336985
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Terminated
• Phase: Phase 1
• Start date: March 28, 2011
• Completion date: March 28, 2011