Status:
Recruiting
Disease Site:
Brain
Phase:
Official Title:
NRG-BN011 Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
NCT ID:
NCT#05095376
Link to Full Details:
Description:
This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell’s DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell’s DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- No known IDH mutation
- Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review
- Willing to use highly effective method of contraception for participants of childbearing potential
- MGMT promoter with methylation confirmed by central pathology review
Exclusion Criteria:
- Prior therapy for tumor, except for resection or prior laser interstitial thermal therapy (LITT). For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed
- Patients on current or planned treatment with any other investigational agents for a study cancer
- Definitive clinical or radiologic evidence of metastatic disease outside the brain
- History of pulmonary fibrosis