Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors.
PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.
详细描述
OBJECTIVES:
- Determine the median time to disease progression in patients with newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.
- Determine the median survival time of these patients treated with this regimen.
- Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic, hematologic, and biochemical profiles in these patients.
- Confirm the maximum tolerated dose of this regimen in these patients.
- Optimize the drug delivery of this regimen in these patients.
- Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of study drug.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed. One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial response, minimal response, or stable disease repeat the above treatments during week 9. Patients with complete response, progressive disease, or unacceptable toxicity receive no additional treatment.
Patients are followed every month until disease progression. All patients regardless of disease progression or retreatment are followed at 36 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA)
- •MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm^3
- •Recurrent GBM and AA must be documented by MRI after the most recent treatment and before any planned surgical debulking
- •At least 5 days since prior surgical debulking
- •No planned resection of newly diagnosed GBM before or during study
- •No bilateral noncontiguous gadolinium enhancing tumors
- •No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip
- •No more than 2 satellite lesions
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 100,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •WBC at least 3,000/mm^3
- •Hepatitis B surface antigen negative
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •SGOT and SGPT no greater than 3 times ULN
- •Alkaline phosphatase no greater than 3 times ULN
- •Lactic dehydrogenase no greater than 3 times ULN
- •Prothrombin time no greater than 1.5 times ULN
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No significant unstable cardiovascular disease
- •No New York Heart Association class III/IV heart disease
- •No evidence of myocardial infarction within the past 3 months
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Human antichimeric antibody (HACA) titer no greater than 48 ng/mL
- •No anatomical or physiological considerations that would preclude study participation
- •No active autoimmune disease, active infection, or traumatic injury requiring treatment
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 8 weeks since prior external beam or gamma knife radiotherapy
- •See Disease Characteristics
- •At least 30 days since prior investigational treatment
排除标准
- 未提供