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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | Columbia 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. The investigators 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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | August 2012 (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, Ph.D. | 212-326-5720 |
| United States, New York | |
| NYU Cancer Institute | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Celeste Rojas Celeste.Rojas@nyumc.org | |
| Principal Investigator: Jasmine Zain, MD | |
| Columbia University Medical Center | Active, not recruiting |
| NY, New York, United States, 10022 | |
| Study Director: | Owen A O'Connor, MD, PhD | Columbia University |
| Principal Investigator: | Jasmine Zain, MD | NYU Langone Medical Center |
| Principal Investigator: | Owen A O'Connor, MD, Ph.D. | Columbia University |
More Information
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00691210 History of Changes |
| Other Study ID Numbers: | AAAJ3001 |
| Study First Received: | June 3, 2008 |
| Last Updated: | February 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Hodgkin's Disease Non-Hodgkin's Lymphoma |
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Etoposide Etoposide phosphate Vorinostat Niacinamide Niacin Nicotinic Acids |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |