|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00081900 |
Purpose
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 |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: DENSPM (diethylnorspermine) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
Drug: DENSPM (diethylnorspermine)
Single 15-minute IV infusion thrice weekly
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908-0708 | |
| McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00081900 History of Changes |
| Other Study ID Numbers: | GD3-165-101 |
| Study First Received: | April 26, 2004 |
| Last Updated: | July 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Carcinoma, Hepatocellular |
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases N(1),N(11)-diethylnorspermine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents |