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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Prednisone — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine Sulfate — DRUG
  Given IV
• Vorinostat — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Oct 6, 2010

Status verified

Oct 2023

Primary completion

Nov 12, 2016

Completion

May 19, 2022

Study Design

Enrollment

107 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (VR-DA-EPOCH)
  Patients receive vorinostat PO QD on days 1-5; rituximab IV on day 1; etoposide IV over 24 hours, doxorubicin hydrochloride IV over 24 hours, and vincristine sulfate IV over 24 hours on days 1-4; prednisone PO daily on days 1-5; and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: ARM B (DA-R-EPOCH)
  Patients receive rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) [ Time Frame: Up to 6 months ]

Locations (35)

Find similar trials in Montgomery, AL

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