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| Sponsor: | New York University |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | New York University |
| ClinicalTrials.gov Identifier: | NCT00691210 |
Purpose
The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs.Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous Tcell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental.Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive nonHodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Disease Non-Hodgkin's Lymphoma |
Drug: Vorinostat (SAHA) and Niacinamide Drug: Vorinostat, Niacinamide and Etoposide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Study of Vorinostat in Combination With Niacinamide, and Etoposide for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies |
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prior Therapy
Contacts and Locations| Contact: Owen A O'Connor, MD, PhD | 212-305-3653 |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| NY, New York, United States, 10032 | |
| Contact: Tasha Smith, MS 212-305-8615 ts2257@columbia.edu | |
| NYU Cancer Institute | Not yet recruiting |
| New York, New York, United States, 10016 | |
| Contact: Victoria Serrano, MPH, CCRP 212-263-4415 Victoria.Serrano@nyumc.org | |
| Principal Investigator: Owen O'Connor, MD, PhD | |
| Principal Investigator: | Owen A O'Connor, MD, PhD | Columbia University |
More Information
| Responsible Party: | Columbia University ( Owen A. O'Connor, MD, PhD ) |
| Study ID Numbers: | AAAD0235 |
| Study First Received: | June 3, 2008 |
| Last Updated: | August 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00691210 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hodgkin's Disease Non-Hodgkin's Lymphoma |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Vasodilator Agents Niacinamide Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Etoposide phosphate Nicotinic Acids Sensory System Agents Therapeutic Uses Vitamins Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Micronutrients Etoposide Lymphoma Hodgkin Disease Immunoproliferative Disorders Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Antilipemic Agents Growth Substances Vorinostat Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions |