Expired Study
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Watertown, Massachusetts 02472


Purpose:

Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent or progressive glioblastoma multiforme.


Study summary:

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.


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% - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL (transfusion allowed) - 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


NCT ID:

NCT00112866


Primary Contact:

Principal Investigator
Mark Gilbert
North American Brain Tumor Consortium


Backup Contact:

N/A


Location Contact:

Watertown, Massachusetts 02472
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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