Phase 2 N=44 Treatment

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00098774 ↗

Enrolled (actual)

Serious AEs

34.1%

Results posted

Sep 2014

Primary outcome: Primary: Complete Response Rate After Remission Induction — 66 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); rituximab (Biological); cytarabine (Drug); etoposide (Drug); leucovorin calcium (Drug); methotrexate (Drug); temozolomide (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Response Rate After Remission Induction	66	—
SECONDARY 4 Year Progression Free Rate	48	—
SECONDARY Change From Baseline in Mini-Mental Status Evaluation at 4 Months	27; 28; 1	—
SECONDARY 4 Year Overall Survival Rate	65	—

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed newly diagnosed primary CNS lymphoma confirmed by 1 of the following methods:
Brain biopsy or resection
Cerebrospinal fluid (CSF) cytology
Positive CSF cytology with or without measurable intracranial disease
No evidence of systemic non-Hodgkin's lymphoma
CT scan or MRI of the chest, abdomen, and pelvis AND bilateral bone marrow biopsy or unilateral biopsy with a 2cm core biopsy specimen that is negative for extracerebral source of lymphoma
Measurable contrast-enhancing disease by MRI of the brain and spine (plus gadolinium) unless CSF cytology positive
No evidence of pleural effusions or ascites

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

ALT and AST ≤ 2 times upper limit of normal
Bilirubin ≤ 2 mg/dL

Renal

Creatinine clearance ≥ 50 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 6 months after study participation
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Concurrent steroids for the management of symptoms related to lymphoma allowed

Radiotherapy

No concurrent palliative radiotherapy

Surgery

Not specified

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00098774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.