Suspended

A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)

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What is being tested

rituximab

Biological
Who is being recruted

Hemic and Lymphatic Diseases+5

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: January 27, 2026
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Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab. Secondary * Determine the progression-free and overall survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.

Official TitleA Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
NCT00072449
Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: January 27, 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

12 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.

Over 18 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

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed primary CNS lymphoma based on 1 of the following: * Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or resection * Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease * Histologically confirmed vitreal lymphoma with measurable intracranial tumor * CD20 positive by brain biopsy * Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI * Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment * No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast * No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry * No ocular lymphoma by slit lamp examination PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin less than 1.5 mg/dL * Transaminases less than 4 times upper limit of normal Renal * Creatinine less than 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study participation * HIV negative * Mini mental status examination score at least 15 * No concurrent serious infection * No other medical illness that would preclude study treatment * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy * More than 90 days since prior biologic therapy * No prior rituximab * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy Surgery * Not specified Other * Recovered from prior therapy * More than 90 days since prior investigational drugs * More than 90 days since prior use of a therapeutic device

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
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

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 9 locations

Suspended

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

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Suspended

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, United States
Suspended

Winship Cancer Institute of Emory University

Atlanta, United States
Suspended

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States
Suspended9 Study Centers