Status:
COMPLETED
Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Subjects will be treated with vorinostat administered orally with daily dosing for 14 days of a 21-day treatment cycle in combination with niacinamide administered orally for 14 days in 21-day treatme...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (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
- 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 unless 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
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3 years
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00691210
Start Date
June 1 2008
End Date
March 1 2015
Last Update
November 20 2020
Active Locations (1)
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1
Center for Lymphoid Malignancies at CUMC
New York, New York, United States, 10019