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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00081900 |
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.Study was terminated after initial assessment of insufficient data to support clinical benefit in this population.
Condition | Intervention | Phase |
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Carcinoma, Hepatocellular |
Drug: DENSPM (diethylnorspermine) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients With Unresectable Hepatocellular Carcinoma |
Estimated Enrollment: | 45 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: DENSPM (diethylnorspermine)
Single 15-minute IV infusion thrice weekly
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
C.Confirmation of the liver lesion by a second imaging modality (US/ CT/ MRI).D.AFP ≥1000 ng/ml, or ≥ 4000 ng/ml if Hepatitis B surface Ag positive.
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
Exclusion Criteria:
United States, Illinois | |
University of Illinois- Chicago | |
Chicago, Illinois, United States, 60612-7323 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana Farber Partners Cancer Care | |
Boston, Massachusetts, United States | |
United States, Tennessee | |
Vanderbilt University School of Medicine | |
Nashville, Tennessee, United States, 37232-6307 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75246 | |
United States, Virginia | |
McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908-0708 |
Study Director: | Medical Monitor | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | GD3-165-101 |
Study First Received: | April 26, 2004 |
Last Updated: | July 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00081900 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Carcinoma, Hepatocellular |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Cardiovascular Agents Antihypertensive Agents Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma N(1),N(11)-diethylnorspermine Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents Carcinoma, Hepatocellular Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Carcinoma |
Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma N(1),N(11)-diethylnorspermine Neoplasms, Glandular and Epithelial |