Phase II Trial of EMD 121974 for Recurrent Glioblastoma : A Clinical Trial With Tissue Correlates of Response
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival rate in operative patients with recurrent
or progressive glioblastoma multiforme treated with cilengitide.
SECONDARY OBJECTIVES:
I. Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment groups for
the preoperative treatment component.
Preoperative Treatment Group I: Patients receive high-dose cilengitide IV over 1 hour on
days -8, -4, and -1.
Preoperative Treatment Group II: Patients receive low-dose cilengitide IV over 1 hour on
days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive
high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4
weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) will be
accrued for this study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
6 months
No
Mark Gilbert
Principal Investigator
North American Brain Tumor Consortium
United States: Food and Drug Administration
NCI-2012-02653
NCT00112866
January 2005
Name | Location |
---|---|
North American Brain Tumor Consortium | Watertown, Massachusetts 02472 |