Trials / Completed
CompletedNCT00082966
Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint. II. To assess time to progression and 2-year overall survival after bortezomib therapy. III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Conditions
- Adult Lymphocyte Depletion Hodgkin Lymphoma
- Adult Mixed Cellularity Hodgkin Lymphoma
- Adult Nodular Sclerosis Hodgkin Lymphoma
- Recurrent Adult Hodgkin Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 17-N-allylamino-17-demethoxygeldanamycin/bortezomib | Given IV |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2007-03-01
- First posted
- 2004-05-17
- Last updated
- 2015-12-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00082966. Inclusion in this directory is not an endorsement.