Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

Conditions

• AIDS-related Diffuse Large Cell Lymphoma
• AIDS-related Immunoblastic Large Cell Lymphoma
• AIDS-related Peripheral/Systemic Lymphoma
• AIDS-related Small Noncleaved Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  Given IV
• etoposide — DRUG
  Given IV
• doxorubicin hydrochloride — DRUG
  Given IV
• vincristine sulfate — DRUG
  Given IV
• prednisone — DRUG
  Given orally
• cyclophosphamide — DRUG
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I, stage II, stage III, or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

Key Dates

Start date

Mar 31, 2003

Status verified

Dec 2012

Primary completion

May 31, 2009

Completion

May 31, 2009

Study Design

Enrollment

106 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I
  Patients receive rituximab intravenously (IV) over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
• Experimental: Arm II
  Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.

Primary Outcome Measure

Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment [ Time Frame: 60 days ]

Locations (1)

Find similar trials in Rockville, MD