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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hodgkin's Disease, Non-Hodgkin's Lymphoma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) of all combinations of drugs used in study as specified in protocol; evaluate the safety and toxicity of the studied combinations of vorinostat, niacinamide and etoposide

Outcome Time Frame:

continuous

Safety Issue:

Yes

Principal Investigator

Owen A O'Connor, MD, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAJ3001

NCT ID:

NCT00691210

Start Date:

June 2008

Completion Date:

September 2013

Related Keywords:

  • Hodgkin's Disease
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Non-Hodgkin's Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Columbia University Medical Center New York, New York  10032