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