Phase II Trial of EMD 121974 for Recurrent Glioblastoma: A Clinical Trial With Tissue Correlates of Response
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 6m-Progression-free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: cilengitide (Drug)
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.
干预措施: therapeutic conventional surgery (Procedure)
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.
干预措施: pharmacological study (Other)
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.
干预措施: laboratory biomarker analysis (Other)
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
干预措施: cilengitide (Drug)
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
干预措施: therapeutic conventional surgery (Procedure)
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
干预措施: pharmacological study (Other)
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
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
6m-Progression-free Survival
时间窗: 6 months
progression within 6 months (26 weeks) of treatment
次要结局
- Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells(Baseline and time of surgery)
- Changes in Vitronectin Expression(Baseline and time of surgery)
- Changes in Tumor Cell Apoptosis(Baseline and time of surgery)
- Changes in Endothelial Cell Apoptosis(Baseline and up to 4 years)
- Tumor Tissue Concentrations(at time of surgery)
- Changes in Tumor Cell Proliferation(Baseline and time of surgery)
- Plasma Concentration of EMD 121974(24 hour post concentration)