A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Study Objectives:
Primary Objective:
To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme.
Secondary Objectives:
To assess the safety of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme.
To evaluate possible differences in efficacy and/or safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels.
Study Design:
Multicenter, open label, randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas, platinum compounds, temozolomide, procarbazine or PCV (procarbazine, lomustine (CCNU) & vincristine). A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed.
详细描述
Study Objectives:
Primary Objective:
To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme.
Secondary Objectives:
To assess the safety of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the study if they meet all of the following criteria:
- •Male or female at least 18 years of age.
- •Histological results confirming GBM are available.
- •Progressive GBM (greater than or equal to 25 percent increase in contrast enhanced tumor CSA compared to the nadir or smallest previous measured CSA) and/or recurrent GBM after conventional treatment, including surgery (biopsy or debulking surgery) and/or radiation therapy and/or chemotherapy.
- •Pre-study MRIs used to determine current progression and/or recurrence of GBM are available to the Investigator and for independent confirmation of progression and/or recurrence.
- •Patient is not considered a candidate for resection.
- •If female of child-bearing potential, a reliable method of contraception must be combined with a negative pregnancy test before entering the study (female patients must be willing to use contraception for 2 months after the last treatment with TransMID (Trademark)). Male patients must be willing to use a barrier method of contraception for up to 2 months after the last treatment with TransMID (Trademark)
- •Able and willing to follow instructions and comply with the protocol.
- •Provide written informed consent prior to participation in the study.
- •Karnofsky Performance Scale Score 70-
- •Tumor characteristics:
- •i) must be unifocal; and
- •ii) must be unilateral and supratentorial; and
- •iii) lesion must have a diameter (on contrast-enhanced MRI) greater than or equal to 1.0 cm and less than or equal to 4.0 cm.
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •Anticipated life expectancy of less than 3 months.
- •Infratentorial or intraventricular tumors.
- •Presence of satellite tumors.
- •Chemotherapy within 30 days prior to study entry or nitrosureas or Mitomycin-C containing therapy within 42 days prior to study entry.
- •Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry.
- •Tumor surgery, tumor debulking or other neurosurgery within 30 days prior to study entry.
- •Previous administration of TransMID (Trademark)
- •Previous enrollment in this study.
- •Regional therapy including administration of biodegradable polymer wafers containing carmustine within 90 days prior to study entry or brachytherapy within 12 calendar months prior to study entry.
- •Significant liver function impairment-(total bilirubin greater than 2.0 mg/dl or 34.2 mircomol/L; AST or ALT greater than 3 times the upper limit of normal).
- •Significant renal impairment (serum creatinine greater than 1.7 mg/dL or 150 micromol/L).
- •Coagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] greater than 1.5 times control).
- •Thrombocytopenia (platelet count less than 100 x 10(3)/micro-L or 100 x 10(9)/L).
- •Granulocytopenia (absolute neutrophil count (ANC), less than 1 x 10(3)/micro-L or 1.0 x 10(9)/L).
- •Severe acute infection.
- •Medical condition that is considered an unacceptable anesthetic risk.
- •Evidence of a mass effect on CT or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness or clinically significant papilledema.
- •Nursing or pregnant females. A pregnancy test will be performed on all females who are of child-bearing potential.
- •Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.