Adult Glioblastoma Clinical Trial
Official title:
A Phase Ib Study of Cediranib in Combination With Cilengitide in Patients With Recurrent Glioblastoma
This phase I trial is studying the side effects and best dose of cediranib maleate when given together with cilengitide in treating patients with progressive or recurrent glioblastoma. Cediranib maleate and cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cediranib maleate together with cilengitide may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the safety profile of cediranib (cediranib maleate) in combination with
cilengitide in patients with recurrent glioblastoma (Part A).
SECONDARY OBJECTIVES:
I. To estimate overall survival. II. To estimate the proportion of radiographic responses in
recurrent glioblastoma patients with measurable disease treated with cediranib and
cilengitide.
III. To estimate the proportion of patients alive and progression free at 6 months (APF6) in
patients with recurrent glioblastoma treated at the safe dose as determined in Part A (Part
B).
IV. To explore potential imaging techniques and biomarkers to capture the disease process
through treatment.
OUTLINE: This is a dose-escalation study of cediranib maleate. Patients are initially
enrolled in the dose-finding portion of the study (part A). Once the safe dose of cediranib
maleate is determined, additional patients are enrolled in the dose-expansion portion of the
study (part B).
Part A (dose finding): Patients receive cediranib maleate orally (PO) once daily on days
1-28 and cilengitide intravenously (IV) over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity.
Part B (dose expansion): Patients are assigned to 1 of 2 groups according to prior anti-VEGF
therapy (yes vs no). Patients in both groups receive cediranib maleate (administered at the
safe dose determined in part A) and cilengitide as in part A.
After completion of study therapy, patients are followed up every 2 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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