NCT00032097已完成1 期
A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.
详细描述
OBJECTIVES:
- Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy.
- Determine the maximum tolerated doses of this drug on these 2 schedules in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients.
- Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients.
- Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients are sequentially assigned to 1 of 2 treatment groups.
- Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks.
- Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy. Patients undergo cranial radiotherapy as in group I.
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
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 supratentorial grade IV astrocytoma
- •Glioblastoma multiforme
- •Previously untreated disease
- •Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •SGOT/SGPT no greater than 4 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 4 times ULN
- •PT/APTT normal
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No uncontrolled hypertension
- •Mini mental state exam score at least 15
- •No history of glucose-6-phosphate dehydrogenase deficiency or porphyria
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast
- •No serious infection
- •No other medical illness that would preclude study participation
- •No allergy to MRI contrast (e.g., motexafin gadolinium)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy or immunotherapy for this disease, including any of the following:
- •Immunotoxins
- •Immunoconjugates
- •Antisense therapy
- •Peptide receptor antagonists
- •Interferons
- •Interleukins
- •Tumor-infiltrating lymphocytes
- •Lymphokine-activated killer cell therapy
- •Gene therapy
- •Chemotherapy:
- •No prior chemotherapy for this disease
- •Endocrine therapy:
- •Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to treatment on this protocol)
- •No other prior hormonal therapy for this disease
- •Radiotherapy:
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00006452Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins6
已完成
1 期
Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic CancerExtrahepatic Bile Duct CancerGallbladder CancerPancreatic CancerNCT00003411University of Pittsburgh
已完成
2 期
Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00022256Memorial Sloan Kettering Cancer Center
已完成
1 期
Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00003409Jonsson Comprehensive Cancer Center
已完成
1 期
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem GliomaUntreated Childhood Brain Stem GliomaNCT00003909National Cancer Institute (NCI)24