A Phase II Trial of Low Dose Fractionated Radiation Therapy as a Chemo-Potentiator of Salvage Temozolomide for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the response rate to salvage temozolomide plus LDFRT.
3, 6 and 12 month follow-up after therapy has been completed
Kristin Redmond, M.D.
Johns Hopkins University
United States: Institutional Review Board
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231|