Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2008 |
| End Date: | March 2015 |
Phase I Study of Vorinostat in Combination With Niacinamide, and Etoposide for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies
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 T-cell 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 non-Hodgkin's lymphoma. However, the way it will be
given in this clinical study is experimental.
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 T-cell 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 non-Hodgkin's lymphoma. However, the way it will be
given in this clinical study is experimental.
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 treatment cycle and etoposide administered intravenously on days 8,9 and 10 of a
21-day treatment cycle. Etoposide dose will be escalated until MTD is determined.
of a 21-day treatment cycle in combination with niacinamide administered orally for 14 days
in 21-day treatment cycle and etoposide administered intravenously on days 8,9 and 10 of a
21-day treatment cycle. Etoposide dose will be escalated until MTD is determined.
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 unless 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. 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
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
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