Suspended

A Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen

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What is being tested

Rituxan

+ Cyclophosphamide

+ Etoposide

Drug
Who is being recruted

Cytopenia+17

+ Blood Platelet Disorders

+ Eye Neoplasms

From 18 Months to 75 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2003
See protocol details

Summary

Principal SponsorOHSU Knight Cancer Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate, in terms of complete response rate, in patients with refractory or recurrent primary CNS lymphoma. Secondary * Determine the overall survival and 2-year progression-free survival of patients treated with this regimen. * Determine the quality of life and cognitive function of patients treated with this regimen. * Determine the neurotoxicity of this regimen in these patients. * Determine the percentage of patients with ototoxicity over time after treatment with this regimen. * Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients. OUTLINE: This is a multicenter study. Patients receive rituximab IV on day 1. On days 2 and 3, patients receive carboplatin intra-arterially over 10 minutes, cyclophosphamide IV over 10 minutes, and etoposide or etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption. Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8 hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on day 14. Beginning 48 hours after the last dose of chemotherapy, patients receive filgrastim (G-CSF)\* subcutaneously (SC) daily for 7-10 days or until blood counts recover. Treatment repeats every 4 weeks for up to 12 courses. NOTE: \* Alternatively, patients may receive a single dose of pegfilgrastim SC, administered 48 hours after the completion of chemotherapy Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam; once weekly for 1 month; and then monthly for 1 year. Quality of life is assessed at baseline, every 3 months during treatment, within 30 days of final treatment, then every 6 months for 1 year, and then annually thereafter. Patients are followed monthly for 3 months, every 2 months for 8 months, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 11-25 patients will be accrued for this study within 7-10 years.

Official TitleA Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen
NCT00074165NCT00261651
Principal SponsorOHSU Knight Cancer Institute
Last updated: January 28, 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

17 patients to be enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 Months to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaBlood Platelet DisordersEye NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsThrombocytopeniaCentral Nervous System NeoplasmsIntraocular LymphomaChemically-Induced DisordersDrug-Related Side Effects and Adverse Reactions

Criteria

16 inclusion criteria required to participate
Signed informed consent form in accordance with institutional guidelines

Histologically or cytologically confirmed primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis

CD20 positive disease

Progressive or relapsed disease during or after completion of prior methotrexate-based chemotherapy

Show More Criteria

6 exclusion criteria prevent from participating
Radiographic signs of intra-cranial herniation and/or spinal block

HIV positive

Systemic lymphoma

Positive serum HCG, pregnant or lactating

Show More Criteria

Study Plan

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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

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 2 locations

Suspended

Good Samaritan Hospital Cancer Treatment Center, Hatton Institute

Cincinnati, United StatesOpen Good Samaritan Hospital Cancer Treatment Center, Hatton Institute in Google Maps
Suspended

Knight Cancer Institute at Oregon Health and Science University

Portland, United States
Suspended2 Study Centers