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Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, Central Nervous System

Eligibility Criteria

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

Inclusion Criteria:

  • All patients must have a histologic diagnosis of non-Hodgkin's lymphoma by brain biopsy. Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial magnetic resonance imaging (MRI) or computed tomography (CT) scan and meet at least one of the following two criteria:

    • A positive cerebrospinal fluid (CSF) cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
    • A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma
  • A typical MRI/CT scan for primary intracranial lymphoma is defined as the presence of hypo, iso, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)
  • Patients must be HIV-1 negative

  • Patients must have a normal or negative pre-treatment systemic evaluation including:

    • A bone marrow aspirate and biopsy
    • CT scans of the chest, abdomen and pelvis
    • Patients must have adequate bone marrow function (defined as peripheral leucocyte count > 4000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg and SGOT < 2 times upper limit of normal), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50 cc/min/1.73M2)
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment

Exclusion Criteria:

The following would exclude a patient from the study:

  • Prior cranial irradiation
  • Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ
  • Pre-existing immunodeficiency such as renal transplant recipient
  • Prior treatment with chemotherapy for CNS lymphoma

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Progression Free Survival
Overall Progression Free Survival at 2 years

Secondary Outcome Measures

Full Information

First Posted
January 7, 2008
Last Updated
April 3, 2017
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Northwestern Memorial Hospital, Columbia University, Kentuckiana Cancer Institute, University of Virginia, University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT00594815
Brief Title
Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Official Title
A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 28, 2002 (undefined)
Primary Completion Date
February 23, 2016 (Actual)
Study Completion Date
February 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Northwestern Memorial Hospital, Columbia University, Kentuckiana Cancer Institute, University of Virginia, University of Vermont

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. The investigators hope that the addition of rituximab will improve the control of the tumor.
Detailed Description
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. We hope that the addition of rituximab will improve the control of your tumor. The second goal of this study is to assess a lower dose of brain radiation. Brain radiation may cause memory loss or dementia. For patients over the age of 60, the risk of significant memory loss is 80-90%. The risk for younger patients is smaller but less clear. In this, study patients whose tumors are in remission after chemotherapy will be treated with a lower dose of brain radiation. We hope that this lower dose will be less toxic. However, it is also possible that using a lower dose of radiation will be less effective in controlling your tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma, Central Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Intervention Description
Immunochemotherapy
Primary Outcome Measure Information:
Title
Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
Description
The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Time Frame
2 years
Title
Progression Free Survival
Description
Overall Progression Free Survival at 2 years
Time Frame
2 Years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have a histologic diagnosis of non-Hodgkin's lymphoma by brain biopsy. Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial magnetic resonance imaging (MRI) or computed tomography (CT) scan and meet at least one of the following two criteria: A positive cerebrospinal fluid (CSF) cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma A typical MRI/CT scan for primary intracranial lymphoma is defined as the presence of hypo, iso, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s) Patients must be HIV-1 negative Patients must have a normal or negative pre-treatment systemic evaluation including: A bone marrow aspirate and biopsy CT scans of the chest, abdomen and pelvis Patients must have adequate bone marrow function (defined as peripheral leucocyte count > 4000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg and SGOT < 2 times upper limit of normal), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50 cc/min/1.73M2) Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment Exclusion Criteria: The following would exclude a patient from the study: Prior cranial irradiation Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ Pre-existing immunodeficiency such as renal transplant recipient Prior treatment with chemotherapy for CNS lymphoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Omuro, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24101038
Citation
Morris PG, Correa DD, Yahalom J, Raizer JJ, Schiff D, Grant B, Grimm S, Lai RK, Reiner AS, Panageas K, Karimi S, Curry R, Shah G, Abrey LE, DeAngelis LM, Omuro A. Rituximab, methotrexate, procarbazine, and vincristine followed by consolidation reduced-dose whole-brain radiotherapy and cytarabine in newly diagnosed primary CNS lymphoma: final results and long-term outcome. J Clin Oncol. 2013 Nov 1;31(31):3971-9. doi: 10.1200/JCO.2013.50.4910. Epub 2013 Oct 7.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

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