A Study to Evaluate the Use of the Drug Combination Vorinostat, Niacinamide, and Etoposide in Patients With Lymphoid Malignancies That Have Reoccurred (SAHA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Determine the maximum tolerated dose (MTD) of all combinations of drugs used in study as specified in protocol; evaluate the safety and toxicity of the studied combinations of vorinostat, niacinamide and etoposide [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Describe the maximum number of cycles received in each part of the study [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Describe the number of dose delays and reductions at the MTD [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Describe the anti-tumor activity [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
- Evaluate pharmacodynamic markers of target effect in paired tissue biopsies [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
-
Drug: Vorinostat (SAHA) and Niacinamide
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's Disease (WHO criteria), for which they are unwilling or unable to undergo an autologous stem cell transplant
- Must have received first line chemotherapy. No upper limit to number of prior therapies
- Evaluable Disease
- Age >18 years
- ECOG performance status <2
- Life expectancy of greater than 3 months
- Patients must have adequate organ and marrow function
- Adequate Contraception
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Prior Therapy
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 7 days prior to the start of the study drugs
- No monoclonal antibody within 3 months without evidence of progression
- Patients may not be receiving any other investigational agents
- Patients with known central nervous system metastases, including lymphomatous meningitis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, niacinamide or etoposide
- Uncontrolled intercurrent illness
- Pregnant women
- Nursing women
- Patient with a history of a prior malignancy
- Patient is known to be Human Immunodeficiency Virus (HIV)-positive
- Active Hepatitis A, Hepatitis B, or Hepatitis C infection
- Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | Recruiting |
| NY, New York, United States, 10022 | |
| Contact: Sean Clark-Garvey, MPH 212-326-5720 sc2359@columbia.edu | |
| Principal Investigator: Owen A. O'Connor, MD, Ph.D. | |
| Principal Investigator: | Owen A O'Connor, MD, Ph.D. | Columbia University |
More Information
No publications provided
| Responsible Party: | Owen A. O'Connor, Professor of Medicine and Experimental Therapeutics; Director, Center for Lymphoid Malignancies, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00691210 History of Changes |
| Other Study ID Numbers: | AAAJ3001 |
| Study First Received: | June 3, 2008 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Hodgkin's Disease Non-Hodgkin's Lymphoma |
Additional relevant MeSH terms:
|
Niacinamide Niacin Nicotinic Acids Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Etoposide Etoposide phosphate Vorinostat |
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 |
ClinicalTrials.gov processed this record on May 19, 2013