Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
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
Sites / Locations
- North American Brain Tumor Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (high-dose cilengitide) 2000mg
Group II (low-dose cilengitide) 500mg
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.
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