|
Liver Perfusion for Patients with Inoperable Liver Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Liver Perfusion for Patients with Inoperable Liver Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Liver Perfusion for Patients with Inoperable Liver Cancer Clinical research trials and Liver Perfusion for Patients with Inoperable Liver Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Liver Perfusion for Patients with Inoperable Liver Cancer. Liver Perfusion for Patients with Inoperable Liver Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Liver Perfusion for Patients with Inoperable Liver Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Liver Perfusion for Patients with Inoperable Liver Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "L" Clinical Trials Conditions > Liver Perfusion for Patients with Inoperable Liver Cancer  Liver Perfusion for Patients with Inoperable Liver Cancer
Liver Perfusion for Patients with Inoperable Liver Cancer
For Condition: Liver Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine the maximum safe dose and side effects of the drug melphalan given through the DelCath system to treat liver cancer. In this system, the chemotherapy is delivered to the liver through special catheters (flexible plastic tubes) inserted through small puncture holes in the groin area into the blood vessels going into and out of the liver. This allows the drug to be administered directly to the liver in amounts that would not be safe if it circulated throughout the body. Patients 14 years of age or older with cancer that has arisen in or spread mainly to the liver and cannot be removed surgically may be eligible for this study. Candidates will be screened with a physical examination, blood tests, electrocardiogram (EKG), chest X-ray, and imaging studies, such as X-ray studies, CT scan of the chest, abdomen and pelvis and MRI scan of the liver, to evaluate the tumor. Other tests may be done if medically indicated. Participants will be admitted to the hospital for treatment under sedation. The groin area is numbed and catheters are placed into the large artery and vein that supply blood to and from the liver, creating a separate circulation for the liver, similar to the heart-lung bypass in open-heart surgery. Once the catheters are in place, melphalan is perfused into the liver for 30 minutes. The circulation to the liver remains separate and the blood is filtered through the DelCath system for another 30 minutes after the drug is given to remove as much of it as possible from the blood coming out of the liver. Following the procedure, patients stay in the intensive care unit for 24 hours for observation. Patients who enter the study early receive lower doses of melphalan. The dose is increased as the study progresses to determine the highest safe and effective dose. Patients will be informed of the progress of the study at the point they enter. Lower doses may be less effective against the tumor, and higher doses may have a greater risk of side effects. Patients stay in the hospital for 3 to 5 days during the perfusion part of the study and return to the outpatient clinic after 3 weeks to evaluate recovery. If recovery is satisfactory, a second treatment will be scheduled. About 4 weeks after the second treatment, the tumor will be evaluated to assess the response to therapy. Patients whose tumor has shrunk or stayed the same will be offered another two treatments. When the treatments are finished, patients will return for evaluation every 3 months for 2 years and then every 4 months for a third year. During these visits they will have a physical examination, imaging scans, X-rays and blood tests to evaluate disease status. If the liver tumor grows or spreads beyond the liver during this time, the patient will be taken off the study and other alternatives for care will be discussed.
Details: Patients with unresectable cancers confined to the liver will undergo a 30 minute hepatic arterial infusion with escalating dose melphalan using extracorporeal hepatic venous charcoal hemofiltration. The dose limiting toxicity and maximum safe tolerated dose of melphalan administrated using this system will be determined. Hepatic and systemic toxicity, melphalan hepatic clearance, filtration efficiency, and pharmacokinetics of melphalan administered in this manner will be determined. In general, patients with resectable disease should be considered for such and those with 4 or fewer lesions that are not considered resectable due to distribution or location in the liver but are less than 7 cm in maximum diameter are eligible for radio-frequency ablation (RFA). Those with unresectable hepatic metastases not suitable for RFA will be considered for isolated hepatic perfusion (IHP). In patients whose condition makes IHP impossible based on factors such as tumor size or location will be considered for this protocol. Patients who have previously failed isolated hepatic perfusion will also be considered candidates for this protocol.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histologically or cytologically proven cancer limited to the parenchyma of the liver. Evidence of limited unresectable extrahepatic disease on preoperative radiological studies is acceptable if the life limiting component of progressive disease is in the liver. In patients whose condition makes isolated hepatic perfusion impossible-based on factors such tumor size or location-will be considered for this protocol. Patients previously treated with IHP with or without hepatic arterial infusion using FUDR will be eligible if they had a bonafide radiographic partial response of 3 months duration to the therapy. Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects. Patients must have an ECOG performance standard of less than 3 on the day prior to treatment. Patients must have adequate hepatic function as evidence by a total serum bilirubin less than or equal to 2.0 mg/dL and a PT within 2 seconds of the upper normal limit. EXCLUSION CRITERIA: Patients with biopsy proven cirrhosis with evidence of 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 indicating an FEV1 less than 30 percent or a DLCO less than 40 percent predicted for age will be excluded. Patients must be 14 years of age or older and greater than 35 kg because of size limitations with respect to percutaneous catheterization of the femoral artery and vein using this system. Patients must have a platelet count greater than 100,000, a Hct greater than 27.0, an ANC greater than or equal to 1.3 microliter and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance of greater than 60 mL/min. Pregnant patients and nursing mothers will be excluded because of the unknown effects of this therapy on the fetus or nursing mothers. Patients taking immunosuppressive drugs or be on chronic anticoagulation will not be eligible. Patients with active infections are not eligible. Patients with severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids are not eligible. Patients with HIV disease are not eligible. 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. Patients with a known prior hypersensitivity reaction to melphalan will be excluded.
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Geoffrey Seidel 3014516742
Additional Information:
Study ID Numbers: 010215; 01-C-0215
Study Start Date: July 23, 2001
Record last reviewed: July 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021606
Other Liver Cancer Studies:
1. Liver Perfusion for Patients with Inoperable Liver Cancer
2. Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
3. Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
4. A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
Related Studies:
Other Liver Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Liver Perfusion for Patients with Inoperable Liver Cancer
|
|
|
|
|
|
|
|
