drugset / Trial / NCT00989352
Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
Phase 2
Unknown
56 enrolled
University Hospital Freiburg
Ludwig-Maximilians - University of Munich · collabUniversity Hospital Heidelberg · collabUniversity Hospital Ulm · collabUniversitätsklinikum Köln · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate, lomustine, and procarbazine\] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\] in patients \> 65 years.
Timeline
- Start
- 2009-09
- Primary completion
- 2011-06
- Completion
- 2011-09
Publications
- Background Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26.
- Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lomustine | Small molecule | 110 mg/m2 | Oral |
| Subject | Methotrexate | Small molecule | 3 g | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | procarbazine | Small molecule | 100 mg | Oral |