Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Approved-not yet active 18 and over Other AAAD0235 NCT00691210

Trial Description

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. 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.

Eligibility Criteria

Inclusion Criteria:

1. Histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's Disease (WHO criteria), for which standard curative or palliative measures do not exist or are no longer effective.

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 4 weeks (6 weeks for nitrosoureas or mitomycin C) 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 30 days prior to the start of the study drugs.

• No monoclonal antibody within 3 months without evidence of progression

• Prior history of receiving etoposide is not a contraindication

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, if CD4 count is less than 200

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

12. Prior or concurrent therapy with any Histone Deacetylase Inhibitor, including valproic acid

Trial Contact Information

Trial Lead Organizations/Sponsors

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Owen A. O'Connor

Principal Investigator

Owen A O'Connor, MD, PhD

Ph: 212-305-3653

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00691210
Information obtained from ClinicalTrials.gov on July 16, 2008