Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine, and Cytarabine With and Without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma

NCT01399372 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Radiation Therapy Oncology Group
Phase	Phase 2
Status	COMPLETED
Enrolment	91
Start date	2011-09
Completion	2022-05-20

Conditions

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

Interventions

• Rituximab
• Cytarabine
• Methotrexate
• Procarbazine
• Vincristine
• low-dose whole-brain radiation therapy

Primary outcomes

• Progression-free Survival — From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.
  Progression is defined as any of the following: more than 25% increase in the contrast-enhancing lesion seen on magnetic resonance imaging (MRI) compared with baseline or best response; new site of disease (central nervous system or systemic); recurrent or new ocular disease; recurrent or positive cerebrospinal fluid (CSF) cytology. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.

Countries

United States, Israel