Clinical Trial Finder

Inclusion Criteria:

• - Histologically confirmed intracranial glioblastoma multiforme (GBM) - Original diagnosis of low-grade glioma with subsequent histological confirmation of GBM allowed.

• - Recurrent disease.

• - Failed prior radiotherapy.

• - Must require a surgical procedure (gross total or near gross total resection) for tumor removal.

• - Performance status - Karnofsky 60-100% - White Blood Count (WBC) ≥ 3,000/mm^3.

• - Absolute neutrophil count ≥ 1,500/mm^3.

• - Platelet count ≥ 100,000/mm^3.

• - Hemoglobin ≥ 10 g/dL (transfusion allowed) - Serum glutamic oxaloacetic transaminase (SGOT) < 2 times upper limit of normal (ULN) - Bilirubin < 2 times ULN.

• - Creatinine < 1.5 mg/dL.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective barrier contraception during and for ≥ 2 weeks after study participation (for female patients) or for 3 months after study participation (for male patients) - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix.

• - No active infection.

• - No other significant uncontrolled medical illness that would preclude study participation.

• - At least 3 weeks since prior interferon.

• - No prior cilengitide.

• - No other prior targeted antiangiogenic treatment (e.g., vatalanib, SU5416, or thalidomide) - No concurrent anticancer immunotherapy.

• - No concurrent routine prophylactic filgrastim (G-CSF) - At least 2 weeks since prior vincristine.

• - At least 3 weeks since prior procarbazine.

• - At least 6 weeks since prior nitrosoureas.

• - No concurrent anticancer chemotherapy.

• - At least 3 weeks since prior tamoxifen.

• - No concurrent anticancer hormonal therapy.

• - See Disease Characteristics.

• - At least 4 weeks since prior radiotherapy.

• - No concurrent anticancer radiotherapy.

• - Recovered from all prior therapies.

• - No more than 3 prior treatments for GBM (1 initial treatment; and treatment for 2 relapses) - For patients who received prior therapy for low-grade glioma, a subsequent surgical diagnosis of high-grade glioma is considered the first relapse.

• - At least 4 weeks since prior investigational agents.

• - At least 4 weeks since prior cytotoxic therapy.

• - At least 3 weeks since other prior non-cytotoxic therapy (e.g., isotretinoin), except radiosensitizers.

• - No other concurrent anticancer therapy.

- No other concurrent investigational agents

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.

Arms

Experimental: Group I (high-dose cilengitide) 2000mg

Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg) 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.

Experimental: Group II (low-dose cilengitide) 500mg

Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (500mg) 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

Interventions

Drug: - cilengitide

Given IV

Procedure: - therapeutic conventional surgery

Undergo tumor resection

Other: - pharmacological study

Correlative studies

Other: - laboratory biomarker analysis

Correlative studies