Evaluating the Addition of Lomustine to Standard Treatment for Newly Diagnosed MGMT Methylated Glioblastoma

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05095376

Provider View

This study explores whether adding the chemotherapy drug lomustine to the usual treatment of temozolomide and radiation can better manage glioblastoma, a type of brain cancer.

Patient Parameters

Program Overview

This phase III clinical trial is investigating whether adding the chemotherapy drug lomustine to the standard treatment of temozolomide and radiation therapy can help shrink or stabilize glioblastoma, a type of brain cancer. Glioblastoma is known for its aggressive nature, and this study focuses on cases where the MGMT gene is methylated, which can affect how the cancer responds to treatment. Chemotherapy drugs like lomustine and temozolomide work by stopping cancer cells from growing, dividing, or spreading. Radiation therapy uses high-energy rays to kill cancer cells. The trial aims to see if the combination of these treatments is more effective than the standard treatment alone.

Description

The main goal of this study is to find out if adding lomustine to the usual treatment of temozolomide and radiation therapy can help patients with newly diagnosed glioblastoma live longer. Glioblastoma is a type of brain cancer, and this study focuses on cases where the MGMT gene is methylated, which can influence treatment response.

Secondary goals include checking if this combination can delay the cancer from getting worse and understanding how it affects patients' quality of life. The study also looks at the side effects of the treatments and how they impact patients' daily lives.

Participants in the study are divided into two groups. One group receives the standard treatment of radiation therapy and temozolomide, while the other group receives radiation therapy, temozolomide, and lomustine. The treatments are given in cycles, with regular follow-ups to monitor progress and side effects.

After finishing the treatment, patients will have check-ups every few months to track their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • No known IDH mutation in the tumor
  • Availability of tumor tissue for central pathology review
  • Contrast-enhanced brain MRI after surgery
  • Willing to use effective contraception during and after treatment
  • Provide informed consent and authorization for health information release
  • Confirmed diagnosis of glioblastoma or gliosarcoma
  • MGMT promoter methylation confirmed
  • No IDH mutation found
  • Recent history and physical examination
  • Karnofsky performance status of 70 or higher
  • Neurologic function assessment
  • Age between 18 and 70 years
  • Adequate blood, kidney, and liver function
  • Undetectable viral load for hepatitis B or C, if applicable
  • HIV-positive patients must have an undetectable viral load
  • Negative pregnancy test for those of childbearing potential

Exclusion Criteria

  • Prior therapy for the tumor, except for surgery or certain laser treatments
  • Current or planned treatment with other investigational agents
  • Evidence of cancer spread outside the brain
  • Prior invasive cancer unless disease-free for at least 2 years
  • Previous head or neck radiotherapy that overlaps with study treatment
  • Pregnancy or unwillingness to stop nursing
  • Allergic reactions to similar drugs
  • History of lung fibrosis
  • Uncontrolled illnesses, such as infections or heart conditions
  • Psychiatric or social issues affecting study compliance
  • No evidence of widespread leptomeningeal disease requiring whole brain irradiation

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