Alopecia
Study Title
A Phase 2 Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy (Protocol No. MITO-02-01)
Study Objectives
The objectives of this study are to determine the safety, pharmacokinetics, and preliminary efficacy of MTS-01 in patients who are undergoing whole brain radiotherapy.
Study Medications
MTS-01 (Tempol; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) is a piperidine nitroxide. The drug product is a topical gel containing 70 mg/mL of Tempol plus water, ethanol, and hydroxypropyl cellulose. The current formulation of MTS-01 is 100 mL of a 70 mg/mL Tempol gel, or a total dose of 7 g, applied uniformly to the scalp. In vitro studies performed at Dow Pharmaceuticals investigated the concentration of reduced Tempol in the dermis following multiple applications (1, 2 and 3) and in concert with gel vehicle (see Appendix). Two applications of Tempol resulted in the highest concentration in the skin. Therefore, a second cohort of patients (8) will be given 200 mL of a 70 mg/mL Tempol gel, or a total dose of 14 g, applied uniformly to the scalp, as two separate applications prior to whole brain irradiation.
Study Design
This study is an open label, phase 2 study of MTS-01 in patients who are scheduled to undergo whole brain radiotherapy for the treatment of brain metastasis.
Study Population
A total of sixteen patients (16) will be enrolled who have a histological diagnosis of brain cancer and who are scheduled to undergo whole brain radiotherapy. Eight of these patients have received a single application of Tempol with a clinical response noted, and with no associated safety concerns. An additional cohort of eight (8) patients will receive two applications of Tempol daily.
Study Duration
The study duration is estimated to be 3 months.
Study Procedures
Patients will be treated with a total radiation dose of 3000 to 3750 cGy given in 10 to 15 daily fractions (i.e., up to 5 days per week for a total of 2 to 3 weeks). Prior to each daily radiation treatment, MTS-01 will be applied to the scalp. Subjects will be evaluated for alopecia weekly during treatment and for 3 weeks following treatment. Safety will be assessed throughout the treatment period and for up to 3 weeks following treatment. Blood samples collected after the first, fifth, and final MTS-01 administration will be measured for Tempol concentration.