Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas

Summary

This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy alone in treating patients with human immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving vorinostat together with combination chemotherapy and rituximab may kill more cancer cells.

Conditions

• AIDS-Related Plasmablastic Lymphoma
• AIDS-Related Primary Effusion Lymphoma
• Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage I Grade 3 Follicular Lymphoma
• Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
• Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
• Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage III Grade 3 Follicular Lymphoma
• Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage IV Grade 3 Follicular Lymphoma
• HIV Infection
• Plasmablastic Lymphoma
• Primary Effusion Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Grade 3 Follicular Lymphoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

DRUG

Vorinostat

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Juan C Ramos · AIDS Malignancy Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-06

Primary Completion

2016-11-12

Completion

2022-05-19

Countries

• United States

Study Locations