Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lymphoma
Started Aug 2002
Longer than P75 for not_applicable lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2002
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2016
CompletedResults Posted
Study results publicly available
April 6, 2017
CompletedApril 6, 2017
April 1, 2017
13.5 years
January 7, 2008
February 13, 2017
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
2 years
Progression Free Survival
Overall Progression Free Survival at 2 years
2 Years
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Northwestern Memorial Hospitalcollaborator
- Columbia Universitycollaborator
- Kentuckiana Cancer Institutecollaborator
- University of Virginiacollaborator
- University of Vermontcollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
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.
PMID: 24101038DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Antonio Omuro
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Omuro, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
August 28, 2002
Primary Completion
February 23, 2016
Study Completion
February 23, 2016
Last Updated
April 6, 2017
Results First Posted
April 6, 2017
Record last verified: 2017-04