Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well rituximab given with combination chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline

Completed

Started Oct 2004

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.9 years study duration

Study Start

First participant enrolled

October 1, 2004

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

11 days until next milestone

Results Posted

Study results publicly available

September 12, 2014

Completed

Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

5.3 years

First QC Date

December 8, 2004

Results QC Date

June 26, 2014

Last Update Submit

July 1, 2016

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

Complete Response Rate After Remission Induction
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
4 months

Secondary Outcomes (3)

4 Year Progression Free Rate
4 years
Change From Baseline in Mini-Mental Status Evaluation at 4 Months
Baseline & month 4
4 Year Overall Survival Rate
4 years

Study Arms (1)

Intensive Combination Chemo & Immunotherapy

EXPERIMENTAL

Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)

Biological: filgrastimBiological: rituximabDrug: cytarabineDrug: etoposideDrug: leucovorin calciumDrug: methotrexateDrug: temozolomide

Interventions

filgrastimBIOLOGICAL

5 mcg/kg subQ injection daily Day 14 until ANC \> or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6)

Also known as: G-CSF