Phase 2 N=6 Treatment

Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Brain and Central Nervous System Tumors · Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00068250 ↗

Enrolled (actual)

Serious AEs

39.0%

Results posted

Feb 2018

Primary outcome: Primary: Number of Phase I Participants Experiencing Toxicity — 1; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rituximab (Drug); methotrexate (Drug); temozolomide 100 mg/m^2 (Drug); temozolomide 150 mg/m^2 (Drug); temozolomide 200 mg/m^2 (Drug); radiation therapy (Radiation); post-radiation therapy temozolomide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Radiation Therapy Oncology Group
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Phase I Participants Experiencing Toxicity	1; 3	—
PRIMARY Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)	80.8	0.006 sig
SECONDARY Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)	18; 12; 2; 3	0.82
SECONDARY Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)	5.4	—

Summary

RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.

Eligibility Criteria

Inclusion criteria

Primary central nervous system (CNS) lymphoma [B-cell, Cluster of Differentiation 20 (CD20) antigen positive] based on positive biopsy or cerebrospinal fluid (CSF) or vitreous cytology (in association with measurable intraparenchymal tumor). Cytology must demonstrate lymphoma or have an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population.
Life expectancy ≥ 8 weeks;
Zubrod performance status of 0-2;
Absolute granulocyte count ≥1500/mm3; platelet count ≥ 100,000/mm3; creatinine clearance ≥ 50, calculated with the Cockcroft-Gault Equation: Cr Clearance = (140-age) x wt (kg)/(Cr[mg/dl]x 72); Bilirubin, serum glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (AST) ≤ 2 x institutional upper limits of normal;
Patients must sign a study-specific informed consent prior to study entry.
Age ≥ 18

Exclusion criteria

Evidence of systemic lymphoma;
Prior malignancy (excluding in situ carcinoma of the cervix or non-melanomatous skin cancer)unless disease free for at least five years;
Prior radiotherapy to the brain or head/neck;
Prior chemotherapy;
History of idiopathic sensitivity to any of the drugs to be used;
Active infectious process;
Seropositive for HIV, AIDS, or post-organ transplant;
Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus.
Active hepatitis B.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00068250). 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.