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A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure Clinical research trials and A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure clinical trial. Human subjects often get the best healthcare possible for their A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure  A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
For Condition: Carcinoma, Hepatocellular
Status: Recruiting
Sponsor(s): Genzyme ,
Synopsis: Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States. First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD, for short). Once that is established, we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used to treat cancer cause side effects (discomforts or illness). In this study, we want to understand what side effects occur in patients with HCC who are treated with DENSPM.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Age 18 - Histologically proven HCC - For recurrent HCC, radiographic evidence of progression. - Not appropriate for curative therapy (surgical resection) or refuses potentially curative therapy - Measurable disease, defined as having at least one measurable intrahepatic tumor lesion (using Response Criteria in Solid Tumors [RECIST]). Prior therapy is acceptable only if there is documented progression of the selected measurable lesion(s) following completion of the therapy. - Required laboratory values - Renal function: serum creatinine 1.2mg/dL Hematologic function: leukocyte count 1,500/mm3, platelet count 50,000/mm3 Hepatic function: transaminases 5x upper limit normal (ULN), albumin 2.0g/dL, total bilirubin 3.5mg/dL Sodium: 130mEq/L - Karnofsky Performance Status of 60% - CLIP Score 3 - If female and of childbearing potential, must use an effective method of contraception - Willing and able to provide written informed consent Exclusion Criteria: - Has received radiotherapy within 6 weeks prior to treatment, Day1. Prior local lesion-specific radiotherapy is acceptable only if the treated lesion(s) is/are not the only source of measurable disease or there is documented progression of the treated lesion(s) following completion of the therapy. - Has received any other non-radiation therapy for HCC within 3 weeks prior to treatment, Day 1. Prior therapy is acceptable only if there is documented progression following completion of the therapy. - Has received another investigational therapy within 30 days prior to study entry - Has any unstable serious or life-threatening medical condition, other than HCC (e.g., unstable angina, other cancer diagnosis with the exception of basal cell carcinoma) - Newly noted clinically significant electrocardiogram (ECG) abnormality - Clinically significant abnormal laboratory result that is not consistent with patient’s clinical course - Active gastrointestinal bleeding resulting in clinically significant hemodynamic changes or a reduction in hemoglobin. - Active inflammatory bowel disease (IBD) and/or active gastric or duodenal ulcer disease - Has a history of central nervous system (CNS) metastases, seizure disorder or neurological exam finding suggestive of CNS metastases - Has Stage C liver cirrhosis according to Child-Pugh-Turcotte classification - Has ascites refractory to diuretic therapy - Has any contraindication for MRI procedure - If female of childbearing potential, has a positive serum HCG - If female, is lactating
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidRyan, Principal Investigator, Massachusetts General Hospital
Massachusetts General Hospital *Not yet recruiting*
Boston, Massachusetts, 02114
United States
Not yet recruiting Jennifer Burns 617-726-6225
University of Illinois- Chicago *Not yet recruiting*
Chicago, Illinois, 60612-7323
United States
Not yet recruiting Lani Krauz 312-355-3782
Vanderbilt University School of Medicine *Not yet recruiting*
Nashville, Tennessee, 37232-6307
United States
Not yet recruiting Carol Caillouette 615-936-1127
McGuire VA Medical Center *Recruiting*
Richmond, Virginia, 23249
United States
Recruiting Edith Gavis 804-675-5584
St. Louis University Hospital *Not yet recruiting*
St. Louis, Missouri, 63110
United States
Not yet recruiting Kili Goudey 314-977-9410
Beth Israel Deaconess Medical Center *Not yet recruiting*
Boston, Massachusetts, 02215
United States
Not yet recruiting Derek Isles 617-667-1954
Additional Information:
Study ID Numbers: GD3-165-101;
Study Start Date: March 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081900
Other Carcinoma, Hepatocellular Studies:
1. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
2. Treatment of hepatocellular carcinoma with Tetrathiomolybdate
3. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer
4. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
5. A phase II multicenter uncontrolled trial of BAY 43-9006 in patients with advanced hepatocellular carcinoma
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A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
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