Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)
|CNS Lymphoma CNS Brain Cancer Non-Hodgkin's Lymphoma||Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)|
- 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 ]
|Actual Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596154
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Lisa DeAngelis, MD||Memorial Sloan Kettering Cancer Center|