NCT00763750

PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors

BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: howard safran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.

Detailed description

To evaluate the safety/tolerability and potential antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
DRUG	PPX +TMZ+XRT	PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-06-01
• Completion: 2012-07-01
• First posted: 2008-10-01
• Last updated: 2020-02-17
• Results posted: 2013-12-16

Locations

1 site across 1 country: United States