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

Stopped early · Phase 1

Conditions studied: Neoplasm Metastases, Melanoma, Colorectal Neoplasms

In brief

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....

Key facts

Study ID: NCT01336985
Run by: National Institutes of Health Clinical Center (CC)
People needed: 5
Starts: 2011-03-28
Expected to finish: 2011-03-28
Last updated by the study team: 2019-12-17

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Significant cardiac or pulmonary insufficiency as evidenced by
history of congestive heart failure with an LVEF < 40%
history of COPD or other chronic pulmonary disease with PFT s indicating an FEV1 less than 30% or a DLCO less than 40% predicted for age
Portal Vein Occlusion or other contraindications to chemoembolization
Inflammatory bowel disease
Prior chemoembolization therapy
Prior precutaneous hepatic perfusion therapy
Prior selective internal radiation therapy (SIRT) with Yttrium-90
Prior biliary diversion surgery
Previous liver resection other than wedge resection.
Pregnant patients and nursing mothers will be excluded because of the unknown effects of this therapy on the fetus or nursing infants.
Patients taking immunosuppressive drugs or requiring ongoing chronic anticoagulation will not be eligible.
Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.
Patients with severe allergic reactions to iodine contrast which cannot be controlled by premedication with antihistamines and steroids are not eligible as a hepatic angiogram is needed for this procedure.
Patients with a known prior hypersensitivity reaction or other contraindication to irinotecan will be excluded.
Patients taking phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John s Wort, or other CYP3A inducers or inhibitors are not eligible for this study.
Patients are prohibited from receiving other experimental agents/adjuvant treatments during the study.
Patients with more than one active primary malignancy, except for basal cell carcinoma or superficial bladder neoplasia, are to be excluded.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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