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A Study to Evaluate the Use of the Drug Combination Vorinostat, Niacinamide, and Etoposide in Patients With Lymphoid Malignancies That Have Reoccurred

Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin's Disease; Non-Hodgkin's Lymphoma

Intervention: Vorinostat (SAHA) and Niacinamide (Drug); Vorinostat, Niacinamide and Etoposide (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Owen A O'Connor, MD, Ph.D., Principal Investigator, Affiliation: Columbia University

Summary

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.

Clinical Details

Official title: Phase I Study of Vorinostat in Combination With Niacinamide, and Etoposide for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Maximum Tolerated Dose of Niacinamide in the Combination of Vorinostat & Niacinamide

Secondary outcome:

The Greatest Number of Cycles Received in Each Treatment Group

Describe the Number of Dose Delays and Reductions at the MTD

Describe the Anti-tumor Activity

Evaluate Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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 2. Must have received first line chemotherapy. No upper limit to number of prior therapies 3. Evaluable Disease 4. Age >18 years 5. ECOG performance status <2 6. Life expectancy of greater than 3 months 7. Patients must have adequate organ and marrow function 8. Adequate Contraception 9. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. 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

2. Patients may not be receiving any other investigational agents 3. Patients with known central nervous system metastases, including lymphomatous meningitis 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, niacinamide or etoposide 5. Uncontrolled intercurrent illness 6. Pregnant women 7. Nursing women 8. Patient with a history of a prior malignancy 9. Patient is known to be Human Immunodeficiency Virus (HIV)-positive 10. Active Hepatitis A, Hepatitis B, or Hepatitis C infection 11. Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs

Locations and Contacts

Columbia University Medical Center, NY, New York 10022, United States
Additional Information

Starting date: June 2008
Last updated: February 25, 2015

Page last updated: August 23, 2015

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