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Liver Perfusion of Melphalan in Inoperable Liver Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Liver Perfusion of Melphalan in Inoperable Liver Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Liver Perfusion of Melphalan in Inoperable Liver Cancer Clinical research trials and Liver Perfusion of Melphalan in Inoperable Liver Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Liver Perfusion of Melphalan in Inoperable Liver Cancer. Liver Perfusion of Melphalan in Inoperable Liver Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Liver Perfusion of Melphalan in Inoperable Liver Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Liver Perfusion of Melphalan in Inoperable Liver Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Liver Perfusion of Melphalan in Inoperable Liver Cancer  Liver Perfusion of Melphalan in Inoperable Liver Cancer
Liver Perfusion of Melphalan in Inoperable Liver Cancer
For Condition: Liver Neoplasm,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study is testing whether administration of a drug called melphalan directly into the liver (isolated hepatic perfusion) can shrink tumors in patients with inoperable cancer whose tumor is confined to the liver. Blood tests and special X-ray studies will be done before treatment and over a period of several months after treatment to evaluate the treatment's effectiveness. Similar perfusion studies with melphalan have been done in patients with cancer (who received another drug together with melphalan) and perfusion of the extremity has been performed in patients with a serious type of skin cancer called melanoma. In both studies tumors shrank, some up to less than half the original size. In some patients, tumors went away completely. Isolated liver perfusion is a major operation, done under general anesthesia. In this procedure, catheters (plastic tubes) are placed into the large blood vessels that deliver blood to and remove blood from the liver, creating a circulation to the liver separate from the rest of the body. During the operation, the liver receives oxygen from an external pump similar to the heart-lung machine used in open-heart surgery. For one hour, melphalan is administered through the pump in large doses that would not be safe if it reached all parts of the body in the normal blood circulation. The entire operation lasts between six and eight hours.
Details: Patients with unresectable cancer confined to the liver will undergo a 60 minute hyperthermic isolated hepatic perfusion with 1.5 mg/kg melphalan. Response to treatment, duration of response, patterns of failure and survival will be followed.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histologically or cytologically proven measurable primary hepatocellular or cholangiocarcinoma, metastatic ocular melanoma, or metastatic islet cell tumors. Patients with colorectal adenocarcinoma limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies will be eligible. Patients with colorectal cancer previously treated with intrahepatic arterial infusion therapy, those with aberrant arterial anatomy such that infusional therapy is not possible, or those with limited extrahepatic disease such that regional therapy is not indicated will be eligible for this protocol. Limited resectable extrahepatic disease includes an untreated asymptomatic primary tumor, malignant periportal lymph nodes, or a single site of hematogenous metastasis to a site such as lung or ovary. Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects. Patients must have an ECOG performance standard of 0, 1 or 2 on the day prior to treatment. Patients must have adequate hepatic function as evidenced by bilirubin less than 2.0 mg/dL and a PT less than or equal to 2 seconds of the upper normal limit Elevations in serum transaminases that are not due to hepatitis are acceptable. Patients must be greater than 30 kg and 18 years of age or older. Patients must have a platelet count greater than 100,000, a Hct greater than 27.0, a white blood count greater than or equal to 2,500/microliter, and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance of greater than 60 ml/min. Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent. EXCLUSION CRITERIA: Pregnant patients and nursing mothers will be excluded. Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible. Patients with active infections are not eligible. Patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be excluded. Patients with a history of congestive heart failure with an LVEF less than 40 percent will be excluded. Patients with COPD or other chronic pulmonary disease with PFT's less than 50 percent predicted for age will be excluded. Patients with a history or diagnosis of VOD will be excluded. Patients with chronic active hepatitis based on a positive serology test for surface antigen B or C will be excluded if there is evidence of cirrhosis on pathology. If no pathology specimen exists then evidence for cirrhosis will be determined based radiological studies and physical examination. If there are no indications of it then the patient will be registered on study and a biopsy will be obtained at the time of lapartomy for IHP with the expectation that occult clincally significant cirrhosis is very unlikely. If cirrhosis is pathologically confirmed the patient will not undergo treatment and be taken off study. Patients with radiographic or other signs of cirrhosis will undergo percutaneous biopsy prior to registration.
Total Enrollment: 67
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 990123; 99-C-0123
Study Start Date: June 22, 1999
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001820
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Liver Perfusion of Melphalan in Inoperable Liver Cancer
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