NCT00390403已完成1 期
A Phase I, Open Label Study of AT-101 Plus Radiotherapy and Temozolomide and of AT-101 Plus Adjuvant Temozolomide for Patients With Newly-Diagnosed Glioblastoma Multiforme
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins16 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gossypol and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Gossypol may help temozolomide work better by making tumor cells more sensitive to the drug. Gossypol may also make tumor cells more sensitive to radiation therapy. Giving gossypol and temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gossypol when given together with temozolomide with or without radiation therapy in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of gossypol (AT-101) when administered with radiotherapy (RT) and concurrent temozolomide (TMZ) in patients with newly diagnosed glioblastoma multiforme.
- Determine the MTD of gossypol when administered with adjuvant TMZ after standard RT and concurrent TMZ in these patients.
Secondary
- Assess the toxicity of these treatment regimens.
- Assess and describe the pharmacokinetics of gossypol.
- Determine, preliminarily, the therapeutic activities of these regimens.
- Determine the relationship between these regimens and cellular and molecular features identified in tumor biopsy specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- •Meets 1 of the following criteria:
- •Completed surgery within the past 6 weeks (group I)
- •Received radiotherapy and concomitant temozolomide at least 4 weeks but no more than 7 weeks prior to start of study treatment (group II)
- •Must be on a stable corticosteroid regimen (no increase for 5 days)
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Hemoglobin ≥ 10 g/dL
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤1.5 mg/dL
- •Bilirubin ≤ 1.5 mg/dL
- •ALT and AST ≤ 2.5 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after completion of study treatment
- •Mini Mental State Exam score ≥ 15
- •Must be able to swallow and retain oral medication
- •No serious concurrent infection or medical illness that would preclude study participation
- •No other malignancy within the past 5 years, except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
- •No sensory neuropathy ≥ grade 2
- •No allergies to gossypol
- •No symptomatic hypercalcemia or hypercalcemia > grade 2
- •No gastrointestinal disease including any of the following:
- •Malabsorption syndrome
- •Disease significantly affecting gastrointestinal function
- •Ulcerative colitis
- •Inflammatory bowel disease
- •Partial or complete small bowel obstruction
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from the immediate postoperative period
- •No prior radiotherapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cells or gene therapy), or hormonal therapy for this brain tumor (group I)
- •Prior glucocorticoid therapy allowed
- •No prior polifeprosan 20 with carmustine implant (Gliadel wafers) (group I)
- •No prior gossypol
- •No prior radiosurgery or brachytherapy
- •No prior resection of the stomach or small intestine
- •No other concurrent anticancer therapy (i.e., chemotherapeutics or investigational agents)
- •No concurrent cytochrome p450 enzyme-inducing anticonvulsant drugs
- •No concurrent prophylactic filgrastim (G-CSF)
- •No concurrent iron supplements
- •Nutritional supplements containing iron allowed
- •No concurrent intensity-modulated radiotherapy
- •No concurrent electron, particle, implant, or stereotactic radiosurgery boost
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
次要结局
- Toxicity
- Pharmacokinetic profile of gossypol
- Therapeutic activity
- Cellular and molecular outcomes (intratumoral expression levels of biomarkers, including Bcl-2 family protein expression [e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, BH3 domain], MGMT gene methylation status, and gene expression array)
研究者
研究点 (16)
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