Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma

NCT00335140 Phase 2 TERMINATED Results posted

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and 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, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.

Details

Lead sponsor	Eastern Cooperative Oncology Group
Phase	Phase 2
Status	TERMINATED
Enrolment	26
Start date	2007-08-23
Completion	2015-07

Conditions

• Lymphoma

Interventions

• Rituximab
• Cytarabine
• Dexamethasone
• Leucovorin
• Methotrexate
• Procarbazine
• Vincristine

Primary outcomes

• Complete Response Rate - Locally Reviewed — For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).
  Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites. Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks.

Countries

United States