Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20
研究概览
简要总结
RATIONALE: Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with sargramostim may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving radiation therapy together with sargramostim and to see how well it works in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the safety of contrast-enhanced high-dose radiotherapy administered with sargramostim (GM-CSF) in patients with advanced solid malignancies.
- Determine immune response in patients treated with this regimen.
- Determine tumor response in patients treated with this regimen.
OUTLINE: Patients are stratified according to prior therapy (biopsy or simple surgery vs radical surgery, chemotherapy, or radiotherapy).
Patients receive a contrast agent intratumorally followed by a single fraction of kilovoltage radiotherapy. Beginning 24 hours after radiotherapy, patients receive sargramostim (GM-CSF) intratumorally continuously for 1 week and then subcutaneously for 2 weeks. Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and then every other week for a total of 3 weeks of drug treatment.
Treatment may repeat in several weeks in the absence of disease progression or unacceptable toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid malignancy
- •Advanced disease
- •Radiotherapy is appropriate treatment (i.e., radio-responsive)
- •No tumors beyond the reach of kilovoltage beam (e.g., > 15 cm beneath the skin)
- •At least 1 lesion accessible to needle localization and catheter placement
- •May be refractory to prior chemotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 2 months
- •Hematopoietic
- •Hemoglobin ≥ 10 g/dL (RBC transfusion allowed)
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3 (transfusion independent)
- •No excessive leukemic blasts
- •No bleeding diathesis
- •PT and PTT ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT < 2 times ULN
- •Alkaline phosphatase < 2 times ULN
- •Creatinine < 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •No contraindication to MRI or CT scan
- •No medical or psychiatric condition that would preclude giving informed consent
- •Able to lie flat for 1 hour
- •No known hypersensitivity to sargramostim (GM-CSF) or any of its components
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior biologic therapy allowed
- •No concurrent biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •No concurrent chemotherapy
- •Endocrine therapy
- •Concurrent hormonal therapy allowed
- •Radiotherapy
- •Prior radiotherapy to planned treatment site allowed
- •No other concurrent radiotherapy to planned treatment site
- •Prior surgery allowed
- •More than 14 days since prior radiosensitizers
- •No other concurrent investigational therapy
排除标准
- 未提供
结局指标
主要结局
Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20
次要结局
- Immune and tumor response as measured by reverse transcriptase polymerase chain reaction (RT-PCR) and CT scan on day 1 and in weeks 2, 3, 4, 12, and 20 or weeks 4, 12, and 20