NRG-BN011

Clinical Trial Title A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
Trial Status Open to Enrollment
Start Date 06/15/2022
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Brain Tumor
Description This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma.
Eligibility Criteria

Eligibility Criteria

  • Age 18-70 years.
  • Karnofsky Performance Status (KPS) ≥ 70 within 28 days.
  • No known IDH mutation.
  • Contrast-enhanced brain MRI within 4 days after surgery.
  • Willing to use highly effective method of contraception for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 6 months after completing treatment.
  • Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma).

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma - Full Text View - ClinicalTrials.gov
Principal Investigator Andrew Kee, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org