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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring primary central nervous system non-Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Winship Cancer Institute of Emory University
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Wake Forest University Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab monotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Radiographic Response
it at any time point patient progresses no more scans are required, patient is off study

Secondary Outcome Measures

Progression-free Survival
pt had MRI every 3 months
Overall Survival
survival was evaluated q 2months
Toxicity
patients only received drug for 8 weeks

Full Information

First Posted
November 4, 2003
Last Updated
June 14, 2013
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072449
Brief Title
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Official Title
A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
slow accrual and lack of resources and priority due to combining 2 consortia
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
primary central nervous system non-Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab monotherapy
Arm Type
Experimental
Arm Description
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Intervention Type
Biological
Intervention Name(s)
rituximab
Primary Outcome Measure Information:
Title
Radiographic Response
Description
it at any time point patient progresses no more scans are required, patient is off study
Time Frame
1 month, 2 months and then q3months
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
pt had MRI every 3 months
Time Frame
pt had MRI q3months
Title
Overall Survival
Description
survival was evaluated q 2months
Time Frame
47 months
Title
Toxicity
Description
patients only received drug for 8 weeks
Time Frame
8 weeks - 2 cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Batchelor, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21383331
Citation
Batchelor TT, Grossman SA, Mikkelsen T, Ye X, Desideri S, Lesser GJ. Rituximab monotherapy for patients with recurrent primary CNS lymphoma. Neurology. 2011 Mar 8;76(10):929-30. doi: 10.1212/WNL.0b013e31820f2d94. No abstract available.
Results Reference
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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

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