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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — BIOLOGICAL
  One 28-day cycle = 500 mg/m\^2 intravenously on day 1 and day 5.
• Cytarabine — DRUG
  One 28-day cycle = 3 g/m\^2 intravenously on day 1 and day 2.
• Methotrexate — DRUG
  One 28-day cycle = 3.5 g/m\^2 intravenously (standard hydration/leucovorin support) on day 2.
• Procarbazine — DRUG
  One 28-day cycle = 100 mg/m\^2 orally on days 2-8.
• Vincristine — DRUG
  One 28-day cycle = 1.4 mg/m\^2 intravenously, dose capped at 2.4mg, on day 2 and day 16.
• low-dose whole-brain radiation therapy — RADIATION
  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.

Study Details

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.

Key Dates

Start date

Sep 30, 2011

Status verified

May 2023

Primary completion

Mar 19, 2020

Completion

May 20, 2022

Study Design

Enrollment

91 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Chemotherapy
  Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
• Experimental: Chemotherapy + Low-Dose WBRT
  Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.

Primary Outcome Measure

Progression-free Survival [ Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years. ]

Locations (44)

Find similar trials in Birmingham, AL

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