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Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery Clinical research trials and Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery. Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery clinical trial. Participants frequently get the best healthcare available for their Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery  Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
For Condition: localized unresectable adult primary liver cancer,advanced adult primary liver cancer,adult primary hepatocellular carcinoma
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Chemoembolization kills tumor cells by delivering drugs directly into the tumor and then blocking the blood flow to the tumor. Combining thalidomide with chemoembolization may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and chemoembolization in treating patients who have liver cancer that cannot be removed by surgery.
Details: OBJECTIVES: - Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses. - Determine the toxicity of this regimen of these patients. - Determine the overall survival of patients treated with this regimen. - Determine the serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and tumor necrosis factor alpha in patients treated with this regimen. OUTLINE: Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure. Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later. Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization. For eligible patients, each lobe is treated separately a second time, in the same sequence, in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven hepatocellular carcinoma OR - Empiric diagnosis of hepatocellular carcinoma based on the presence of a hypervascular mass on angiography AND known cirrhosis or chronic hepatitis B or C - Ineligible for potentially curative surgical resection - Must be a candidate for palliative chemoembolization - MRI must show one or more discrete tumor nodules that can be targeted by angiography for chemoembolization - No diffusely infiltrating tumor - At angiography, lesions under consideration for chemoembolization must demonstrate substantial hypervascularity PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,200/mm^3 - Hemoglobin at least 8.0 g/dL - Platelet count at least 50,000/mm^3 Hepatic: - SGOT and SGPT no greater than 5 times normal - Bilirubin less than 3 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Other: - No other medical condition that would preclude study - No other malignancy within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Regardless of fertility status: - All female patients (unless they have undergone a hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study - All male patients (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior interferon for hepatitis allowed - No prior biologic therapy for hepatocellular carcinoma Chemotherapy: - No prior chemotherapy for hepatocellular carcinoma Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent barbiturates or alcohol
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlecGoldenberg, Study Chair, Kaplan Cancer Center
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Mount Sinai School of Medicine *Recruiting*
New York City, New York, 10029
United States
Recruiting Max Sung 212-241-6756
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Alec Goldenberg 212-263-2173
Additional Information:
Study ID Numbers: CDR0000068025; NYU-9937,NCI-99
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006016
Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. DX-8951f in Treating Patients With Liver Cancer
2. T900607 in Treating Patients With Unresectable Liver Cancer
3. Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
4. Doxorubicin and Interleukin-2 in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
5. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
Related Studies:
Other localized unresectable adult primary liver cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
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