NCT00128635已完成1 期
An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme.
PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B in treating patients with progressive or recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme.
Secondary
- Determine the biodistribution and radiation dosimetry of this drug in these patients.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the overall survival, median time of survival, and 6-month survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed glioblastoma multiforme
- •Focal disease
- •Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy
- •Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed
- •Gross tumor volume 5-60 mL
- •No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles
- •No bilateral non-contiguous gadolinium-enhancing tumor
- •No diffuse disease, defined as any satellite lesion > 1.5 cm from the anticipated location of a catheter tip OR > 2 satellite lesions
- •No ventricular invasion outside the anticipated radiotherapy volume
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin ≤ 1.5 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Hepatitis B negative
- •No evidence of active hepatitis
- •Creatinine ≤ 1.7 mg/dL
- •BUN ≤ 2 times ULN
- •Cardiovascular
- •No uncontrolled hypertension
- •No unstable angina pectoris
- •No uncontrolled cardiac dysrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to undergo MRI
- •Mini Mental State Exam score ≥ 15
- •No serious infection
- •No other medical illness that would preclude study participation
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- •No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance
- •No known or suspected allergy to study drug or iodine
- •No known HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior monoclonal antibodies
- •No prior local immunotherapy or treatment with the following biologic agents:
- •Immunotoxins
- •Immunoconjugates
- •Antiangiogenesis compounds
- •Antisense agents
- •Peptide receptor antagonist
- 另有 20 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
次要结局
- Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days
- Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks
- Overall survival, median time of survival, and percent alive at 6 months
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
1 期
Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast CancerBreast CancerNCT00003920University of California, Davis18
已完成
不适用
Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's LymphomaLymphomaNCT00416312Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins9
已完成
2 期
Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's LymphomaLymphomaNCT00005592University of Alabama at Birmingham23
已完成
2 期
Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's LymphomaLymphomaNCT00073931Fred Hutchinson Cancer Center25
已完成
2 期
S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's LymphomaLymphomaNCT00107380SWOG Cancer Research Network86