Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, vorinostat
Phase phase 2
Targets CD20, HDAC
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date July 2008
End date October 2017
Trial size 33 participants
Trial identifier NCT00720876, 07195, CDR0000600989, NCI-2010-00531, P30CA033572

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab
Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat
200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.

Primary Outcomes

Measure
Response rate (complete and partial response)
time frame: 1 year after the start of treatment

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma
      Principal investigator Robert Chen, MD
      Description OBJECTIVES: - 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.
      Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
      Information provided to ClinicalTrials.gov by City of Hope Medical Center.