Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00596154|
Recruitment Status : Active, not recruiting
First Posted : January 16, 2008
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|CNS Lymphoma CNS Brain Cancer Non-Hodgkin's Lymphoma||Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)|
|Actual Study Start Date :||December 2004|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Rituximab, methotrexate (MTX), procarbazine and vincristine (R-MPV). The peripheral blood stem cell (PBSC) harvest procedure will be performed at the discretion of the hematology attending (usually after the 1st or 2nd cycle of R-MPV)and high dose chemotherapy Busulfan, Thiotepa, and Cyclophosphamide.
Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide
The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.
On day 2 you will be admitted to the hospital and will receive 3 other drugs:
Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.
Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.
- to evaluate the safety and efficacy of the use of R-MPV followed by high-dose chemotherapy using thiotepa, cyclophosphamide and busulfan with stem cell rescue in patients with newly diagnosed PCSNL. [ Time Frame: 1-year event-free survival and acute treatment-related toxicity. ]
- to evaluate response rates with the combination of rituximab and MPV as induction chemotherapy. [ Time Frame: after 5 cycles ]
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): NCT00596154
|United States, New Jersey|
|Memorial Sloan Kettering Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan Kettering Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Christian Grommes, MD||Memorial SloanKettering Cancer Center|