An International, Multi-Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme
Status: Terminated
Location: See all (10) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of the study is to determine the effectiveness of an investigational drug called lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of Glioblastoma Multiforme (GBM).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 and 70 years of age in India, 18 years and above in US
• Histologically proven GBM who
‣ May or may not have undergone surgery
⁃ Is scheduled to receive treatment with temozolomide and radiation.
• Karnofsky score ≥ 70%.
Locations
United States
California
UCSD Moores Cancer Center
La Jolla
UCI Medical Center
Orange
New York
Dent Neurologic Institute
Amherst
Ohio
Cleveland Clinic
Cleveland
Fairview Hospital Moll Cancer Center/Cleveland Clinic
Cleveland
Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic
Mayfield
Other Locations
India
Gujarat Cancer Research Institute
Ahmedabad
Bhagwan Mahaveer Cancer Hospital & Reseach Centre
Jaipur
Chittaranjan National Cancer Institute
Kolkata
Jaslok Hospital & Research Centre
Mumbai
Time Frame
Start Date: 2012-06-19
Completion Date: 2013-04-15
Participants
Target number of participants: 18
Treatments
Placebo_comparator: Placebo
Participants will receive a matching placebo as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
Active_comparator: Lucanthone
Participants will receive Lucanthone as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
Authors
Related Therapeutic Areas
Sponsors
Leads: Spectrum Pharmaceuticals, Inc