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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Merck |
| Information provided by (Responsible Party): | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00720876 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: vorinostat |
Phase II |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 33 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral vorinostat twice daily on days 1-14 and rituximab IV on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed indolent non-Hodgkin lymphoma, including any of the following subtypes:
Newly diagnosed or relapsed/refractory disease
No known brain metastases
PATIENT CHARACTERISTICS:
Total bilirubin normal
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No more than 4 prior chemotherapy regimens
No concurrent complementary and alternative medicine (CAM) therapy
Contacts and Locations| United States, California | |
| Tower Cancer Research Foundation | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Solomon I. Hamburg, MD, PhD 310-888-8680 | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Joel Conrad 800-826-4673 | |
| City of Hope Medical Group | Recruiting |
| Pasadena, California, United States, 91105 | |
| Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
| Principal Investigator: | Robert Chen, MD | City of Hope Medical Center |
More Information
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00720876 History of Changes |
| Other Study ID Numbers: | 07195, P30CA033572, CDR0000600989, NCI-2010-00531 |
| Study First Received: | July 22, 2008 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma |
stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma contiguous stage II marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma noncontiguous stage II marginal zone lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma stage I marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma recurrent mantle cell lymphoma |
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Vorinostat |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |