Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving vorinostat together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with rituximab and to see how well it works in treating patients with indolent non-Hodgkin lymphoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma|
- Response rate (complete and partial response) [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 3 weeks after the stop of treatment ] [ Designated as safety issue: Yes ]
- Effects of treatment on systemic levels of immune cytokines, evaluated by cytokine bead array using Luminex X-MAP bead array technology [ Time Frame: Baseline and on day 14 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Vorniostat and Rituximab
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.Drug: vorinostat
200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
- To evaluate the anti-tumor activity of vorinostat and rituximab, in terms of objective response rate, time to progression, and survival, in patients with indolent non-Hodgkin lymphoma.
- To assess the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive oral vorinostat twice daily on days 1-14 and rituximab IV on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720876
|United States, California|
|Tower Cancer Research Foundation|
|Beverly Hills, California, United States, 90211|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Robert Chen, MD||City of Hope Medical Center|