NCT00335140|TerminatedPhase 2ResultsFDA Drug

Study Stopped

slow accrual

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

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

Eastern Cooperative Oncology Group ClinicalTrials.gov

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2 other identifiers

CDR0000475776ECOG-E1F05

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2006

StartedAug 2007

CompletionJul 2015

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline

Completed

Started Aug 2007

Typical duration for phase_2 lymphoma

Geographic Reach

1 country

68 active sites

Status

terminated

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

7.9 years study duration

First Submitted

Initial submission to the registry

June 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed

1.2 years until next milestone

Study Start

First participant enrolled

August 23, 2007

Completed

7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed

2 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed

Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

7.9 years

First QC Date

June 7, 2006

Results QC Date

April 17, 2017

Last Update Submit

June 14, 2023

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

Complete Response Rate - Locally Reviewed
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.
For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).

Study Arms (1)

Rituximab + standard chemotherapy

EXPERIMENTAL

Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.

Biological: RituximabDrug: CytarabineDrug: DexamethasoneDrug: LeucovorinDrug: MethotrexateDrug: ProcarbazineDrug: Vincristine

Interventions

RituximabBIOLOGICAL

Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.

Also known as: Rituxan