Completed
Protocol-A

Combination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma

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What is being tested

Data Collection

Who is being recruted

Immune System Diseases
+4

+ Immunoproliferative Disorders
+ Lymphatic Diseases
From 16 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2000
See protocol details

Summary

Principal SponsorOHSU Knight Cancer Institute
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2000Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine in patients with primary CNS lymphoma. Secondary * Determine the ability to recruit adequate numbers of patients for this study. * Compare progression-free and dementia-free survival with standard measures of overall survival, progression-free survival, disease-free survival, complete response rate, cognitive function, and quality of life of patients treated with this regimen. * Determine the feasibility of conducting a future phase III study of this treatment regimen in these patients. * Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. * Induction chemotherapy: Patients receive methotrexate IV over 3 hours on days 1, 10, and 20 and intraventricularly or intrathecally (IT) over 5 minutes on days 1, 5, 10, and 15; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on days 1, 5, 10, and 15. Treatment repeats every 42 days for a total of 3 courses. Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam. Patients with stable or responding disease proceed to maintenance therapy. * Maintenance chemotherapy: Patients receive methotrexate IV over 3 hours and IT over 5 minutes on day 1; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on day 1. Treatment repeats every 42 days for a total of 5 courses. Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1 month and then monthly for 1 year. Quality of life is assessed at baseline, at 6 months, at the completion of treatment, every 6 months for 2 years, and then annually thereafter. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 3 years.

Official TitleCombination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma 
NCT00074191
Principal SponsorOHSU Knight Cancer Institute
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1 patient to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 16 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis * Diagnosed within the past 90 days * No systemic lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age * 16 to 75 Performance status * ECOG 0-3 OR * Karnofsky 40-100% Life expectancy * Not specified Hematopoietic * WBC at least 2,500/mm\^3 * Hematocrit at least 25% (transfusion allowed) * Absolute granulocyte count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 OR at least lower limit of normal (transfusion independent) Hepatic * Bilirubin no greater than 2.0 times upper limit of normal Renal * Creatinine clearance at least 30 mL/min Cardiovascular * Adequate cardiac function to tolerate general anesthesia Pulmonary * Adequate pulmonary function to tolerate general anesthesia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 2 months before and during study participation * No other uncontrolled, clinically significant confounding medical condition within the past 30 days * No known allergy to study agents * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * Single-agent methotrexate administered within the past 14 days allowed Endocrine therapy * Not specified Radiotherapy * No prior cranial or spinal radiotherapy Surgery * Prior surgery or biopsy allowed


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Oregon Health & Science University Cancer InstitutePortland, United StatesSee the location

CompletedOne Study Center
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