Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT00720876|
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : June 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: vorinostat||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||July 23, 2008|
|Actual Primary Completion Date :||June 8, 2017|
|Actual Study Completion Date :||June 8, 2017|
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.
- Response rate (complete and partial response) [ Time Frame: 1 year after the start of treatment ]
- Time to progression [ Time Frame: 1 year after the start of treatment ]
- Overall survival [ Time Frame: 1 year after the start of treatment ]
- Toxicity [ Time Frame: 3 weeks after the stop of treatment ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|