Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with relapsed B-cell non-Hodgkin's lymphoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)|
- Objective tumor response as assessed by positron emission tomography with fludeoxyglucose (FDG-PET) and the International Workshop Standardized Criteria for Non-Hodgkin's lymphoma [ Designated as safety issue: No ]
- Measurability of tumor lesions as assessed by FDG-PET and CT scan at baseline [ Designated as safety issue: No ]
- Duration of overall response [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Time to response [ Designated as safety issue: No ]
- PFS rate at 3 and 6 months [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
- Determine the antitumor effectiveness of suberoylanilide hydroxamic acid, as measured by overall objective response rate, in patients with relapsed diffuse large B-cell lymphoma.
- Determine the duration of response and time to response in patients treated with this drug.
- Determine progression-free survival, time to progression, and 3- and 6-month progression-free survival rates in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 1 year.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095|
|Study Chair:||Sven De Vos, MD||Jonsson Comprehensive Cancer Center|