Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
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|ClinicalTrials.gov Identifier: NCT00594815|
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma|
|Study Start Date :||August 28, 2002|
|Actual Primary Completion Date :||February 23, 2016|
|Actual Study Completion Date :||February 23, 2016|
Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
- Total Number of Participants Who Experienced Acute Treatment Related Adverse Events [ Time Frame: 2 years ]The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
- Progression Free Survival [ Time Frame: 2 Years ]Overall Progression Free Survival at 2 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594815
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Antonio Omuro, MD||Memorial Sloan Kettering Cancer Center|