Trials / Completed
CompletedNCT00132028
Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma
A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the response probability (complete, complete unconfirmed, and partial) in patients with relapsed or refractory Hodgkin's lymphoma. II. To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkin's lymphoma treated with SAHA. III. To assess the toxicity profile of SAHA in this patient population. IV. To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results. OUTLINE: This is a multicenter study. Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
Conditions
- Adult Favorable Prognosis Hodgkin Lymphoma
- Adult Lymphocyte Depletion Hodgkin Lymphoma
- Adult Lymphocyte Predominant Hodgkin Lymphoma
- Adult Mixed Cellularity Hodgkin Lymphoma
- Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
- Adult Nodular Sclerosis Hodgkin Lymphoma
- Adult Unfavorable Prognosis Hodgkin Lymphoma
- Recurrent Adult Hodgkin Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vorinostat | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2005-08-19
- Last updated
- 2014-05-23
- Results posted
- 2012-09-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00132028. Inclusion in this directory is not an endorsement.