To evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.
In vitro and in vivo studies have suggested that low dose fractionated radiation therapy (LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of resistance found with standard doses of radiation and chemotherapy. This is a nonrandomized, open label, single institution phase II trial with a safety run-in to evaluate the safety and efficacy of LDFRT plus temozolomide in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) previously treated with surgical resection followed by adjuvant radiation therapy plus temozolomide. The primary objective of the phase II study is to estimate response rate in patients treated with twice daily fractions of low dose radiation plus temozolomide chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If \> 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below.
All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression.
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Response Rate
To estimate the response rate to salvage temozolomide plus LDFRT.
Time frame: 3, 6 and 12 month follow-up after therapy has been completed
Overall Survival Rate
Overall survival rate is calculated as the median number of months that patients were alive for the cohort
Time frame: up to 12 months after completion of temozolomide (48 weeks of treatment)
Progression Free Survival Rate
Progression free survival rate is calculated as the median number of months for the cohort until patient's disease worsened/progressed
Time frame: up to 12 months after completion of temozolomide (48 weeks of treatment)
Number of Patients With Hematologic Toxicities
The number of patients with grade 3+ hematologic toxicities.
Time frame: Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up
Number of Patients With Neurologic Toxicity
The number of patients with reported grade 3+ neurologic toxicities
Time frame: Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up
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