Study on Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

Sponsor: University of Louisville

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01985087

Provider View

This clinical trial is exploring the effects of combining radiation therapy with the drug temozolomide to treat glioblastoma in patients aged 70 and older. The study aims to determine how well this treatment works and how it affects patients' health.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the outcomes of patients aged 70 or older who are treated with a combination of radiation therapy and the drug temozolomide. Radiation will be administered over a two-week period, and temozolomide will be given daily during this time. After radiation, patients will continue taking temozolomide for up to six cycles or until the disease progresses, with doses ranging from 150 mg/m2 to 200 mg/m2.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of glioblastoma or gliosarcoma.
  • Tumor must be tested for a specific genetic marker (MGMT promoter methylation).
  • Must not have received any previous treatment for glioblastoma, including radiation or chemotherapy.
  • Must be over 70 years old.
  • Must have a life expectancy of more than 6 months.
  • Must have a performance status score indicating they are able to carry out daily activities with some help.
  • Must have normal organ and bone marrow function, including:
    • White blood cell count above 3,000/microliter
    • Neutrophil count above 1,500/microliter
    • Platelet count above 100,000/microliter
    • Normal bilirubin levels
    • Liver enzymes (SGOT/SGPT) less than 2.5 times the normal limit
    • Normal kidney function or creatinine clearance above 60 mL/min/1.73 m2
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot be participating in another study.
  • Cannot have had chemotherapy wafers placed during surgery.
  • Cannot have allergies to temozolomide or similar drugs.
  • Cannot have uncontrolled health issues like infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that would affect participation.
  • Cannot have had another cancer unless they have been cancer-free for at least 3 years, except for certain skin cancers or cervical cancer treated within the last 5 years.
  • Cannot be HIV-positive and on antiretroviral therapy due to potential drug interactions and increased risk of infections.

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