Brain and Nervous System Clinical Trial
Official title:
A Phase 1B Trial Nivolumab Consolidation Following Completion of High-Dose Methotrexate Containing Induction Chemotherapy in Older (≥ 65) Patients With Primary CNS Lymphoma
The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls
This is a 2-stage phase 1B study of nivolumab consolidation following completion of HD-MTX containing induction chemotherapy in older (≥ 65 years old) patients with previously untreated primary CNS lymphoma. Stage 1 is designed to evaluate the safety of nivolumab consolidation. We plan to use 3+3 design and start at the FDA approved single agent dose of nivolumab 480 mg intravenously every 4 weeks. Stage 2 is designed to evaluate the safety as well as efficacy of nivolumab consolidation after HD-MTX containing induction chemotherapy in an expansion cohort. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01778764 -
Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases
|
||
| Completed |
NCT00251797 -
A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
|
Phase 1 | |
| Withdrawn |
NCT04770831 -
Patients Who Receive 131 I-MIBG
|
||
| Recruiting |
NCT05474378 -
B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT03076255 -
Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
|
N/A |