NCT00769990撤回1 期
Phase I-II Trial of Genistein in Subjects Receiving Palliative External Beam Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Genistein may increase the effectiveness of radiation therapy in treating pain caused by bone metastases.
PURPOSE: This phase I/II trial is studying the side effects of genistein and to see how well it works in treating patients undergoing external-beam radiation therapy for pain caused by bone metastases.
详细描述
OBJECTIVES:
- To determine whether genistein is safe when administered in combination with palliative external beam radiotherapy in patients with osseous metastases.
- To determine the time to pain relief, duration of pain relief, and degree of pain relief in patients treated with this regimen.
- To determine the incidence of pathologic fractures in patients treated with this regimen.
- To determine the effect of this regimen on quality of life measures in these patients.
OUTLINE: This is a multicenter study.
Patients undergo external beam radiotherapy once daily on days 1-10. Patients also receive oral genistein once daily on days 1-60.
Patients complete pain and quality-of-life questionnaires periodically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed malignant solid tumor, including any of the following:
- •Breast cancer
- •Lung cancer
- •Kidney cancer
- •Prostate cancer
- •Radiographic evidence* of bone metastasis within the past 8 weeks NOTE: *Acceptable studies include plain radiograph, radionuclide bone scan, CT scan, and MRI
- •Has pain that appears to be related to the radiographically documented metastasis, in the opinion of the treating physician, AND a decision has been made by the responsible clinician that a course of palliative external beam radiotherapy is appropriate treatment
- •"Worst pain score" of > 5 on a scale of 10 as scored on the pain assessment questionnaire (BPI) (question #3: 0 = no pain; 10 = worst possible pain) OR taking narcotic medications with an oral morphine equivalent dose of > 60 mg/day
- •No painful metastases to the skull, hands, or feet
- •Eligible treatment sites include any of following:
- •Weight-bearing sites:
- •Pelvis (excluding pubis)
- •Sacrum and/or sacroiliac joints
- •Non-weight-bearing sites:
- •Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
- •Lumbosacral spine
- •Up to 3 consecutive ribs
- •Radius ± ulna
- •If multiple osseous sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur, or tibia
- •Treatment of multiple osseous sites allowed only if those sites can be included in ≤ 3 treatment sites
- •Patients with painful metastases that are contiguous but do not fit into the definition of a site listed above are eligible but are considered to have 2 treatment sites
- •No vertebral metastases with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
- •No primary hematologic malignancies (e.g., lymphoma)
- •Hormone receptor status (for patients with breast cancer):
- •Estrogen receptor-negative tumor
- •Menopausal status not specified
- •Karnofsky performance status 40-100%
- •Life expectancy ≥ 3 months
- •ALT normal
- •Bilirubin normal
- •Serum creatinine normal (≤ 1.8 mg/dL for males and ≤ 1.5 mg/dL for females)
- •Free T4 and thyroid-stimulating hormone normal
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No pathologic fracture or impending fracture of the treatment site
- •No history of primary hyperparathyroidism
- •No malabsorptive disease or chronic diarrhea
- •No history of sarcoidosis or tuberculosis
排除标准
- •Less than 30 days since prior systemic radioisotopes for pain, including Strontium-90 (^90Sr) or Samarium (^153Sm)
- •Less than 30 days since prior antibiotics
- •Less than 30 days since prior initiation of systemic therapy (e.g., hormonal therapy, chemotherapy, or immunotherapy)
- •Less than 90 days since prior intravenous bisphosphonate therapy
- •Concurrent oral bisphosphonates allowed
- •Prior radiotherapy or palliative surgery to the painful sites
- •Concurrent surgical fixation of the bone
- •Concurrent treatment to the skull, hands, or feet
研究组 & 干预措施
Genistein
Experimental
Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.
干预措施: genistein (Dietary Supplement)
Genistein
Experimental
Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Safety
时间窗: At completion of first 6 patients
Frequency of severe (grade 3) toxicities
次要结局
- Time to pain relief, duration of pain relief, and degree of pain relief
- Incidence of pathologic fractures
- Effect of treatment on quality of life measures as assessed by the BPI and FACT-G
研究者
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