Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill cancer cells. It is not yet know whether rituximab and combination chemotherapy are more effective when given with or without radiation therapy in treating patients with primary central nervous system lymphoma.

PURPOSE: This randomized phase II trial studies how well giving rituximab and combination chemotherapy with or without radiation therapy works in treating patients with primary central nervous system lymphoma.

Conditions

• Chemotherapeutic Agent Toxicity
• Cognitive/Functional Effects
• Lymphoma
• Neurotoxicity
• Radiation Toxicity

Interventions

BIOLOGICAL

Rituximab

One 28-day cycle = 500 mg/m\^2 intravenously on day 1 and day 5.

DRUG

Cytarabine

One 28-day cycle = 3 g/m\^2 intravenously on day 1 and day 2.

DRUG

Methotrexate

One 28-day cycle = 3.5 g/m\^2 intravenously (standard hydration/leucovorin support) on day 2.

DRUG

Procarbazine

One 28-day cycle = 100 mg/m\^2 orally on days 2-8.

DRUG

Vincristine

One 28-day cycle = 1.4 mg/m\^2 intravenously, dose capped at 2.4mg, on day 2 and day 16.

RADIATION

low-dose whole-brain radiation therapy

Total dose of 2340 cGy administered as 13 daily fractions of 180 cGy over 3 weeks. Participants with progressive disease on magnetic resonance imaging (MRI) do not receive WBRT.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Antonio Omuro, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2020-03-19

Completion

2022-05-20

Countries

• United States
• Israel

Study Locations