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Cediranib Maleate and Cilengitide in Treating Patients With Progressive or Recurrent Glioblastoma

2014-08-27 03:19:13 | BioPortfolio

Summary

RATIONALE: 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.

PURPOSE: 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.

Description

OBJECTIVES:

Primary

- To determine the safety profile of cediranib maleate in combination with cilengitide in patients with progressive or recurrent glioblastoma.

Secondary

- To estimate the overall survival of patients treated with this regimen.

- To estimate the proportion of radiographic responses in patients with measurable disease treated with this regimen.

- To estimate the overall and progression-free survival rate at 6 months in patients treated with cediranib maleate (administered at the safe dose determined in the dose-finding portion of the study) in combination with cilengitide.

- To explore potential imaging techniques and biomarkers to capture the disease process through treatment.

OUTLINE: This is a two-part, multicenter study. 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 oral cediranib maleate once daily on days 1-28 and cilengitide 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.

Patients enrolled in part B undergo blood sample collection at baseline and periodically during study to measure collagen IV, tumastatin, and other angiogenic biomarkers (e.g., VEGF-A, VEGF-D, sVEGFR1, sVEGFR2, sICAM1, sVCAM1, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, thrombospondin-1, Ang1, bFGF, IL-6, and IL-8) by ELISA assays and circulating endothelial cell levels by immunostaining and flow cytometry. Some patients in part B also undergo MRIs at baseline and periodically during study for correlative imaging studies.

After completion of study therapy, patients are followed up every 2 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

cediranib maleate, cilengitide, enzyme-linked immunosorbent assay, flow cytometry, laboratory biomarker analysis, magnetic resonance imaging

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:13-0400

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