NCT00678054已完成2 期
A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PSA Response
研究概览
简要总结
This is a Phase II study to test the efficacy of exogenously administered GM-CSF in prostate cancer patients who have failed definitive local therapy, and have only serologic (PSA) evidence of progression.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of adenocarcinoma of the prostate; stage T1-T3, N0-N1, M0
- •Prior definitive therapy for primary prostate cancer consisting of:external beam radiotherapy;brachytherapy with or without pelvic external beam radiation; or radical prostatectomy with or without adjuvant or salvage radiation therapy
- •Therapeutic PSA response to primary therapy below 1.0 ng/ml post radiation therapy or below 0.4 ng/ml for radical prostatectomy
- •Patients treated with adjuvant or salvage radiation therapy following radical prostatectomy are eligible provided:Post prostatectomy PSA was never > 6.0 ng/ml, last effective day of androgen deprivation is at least 3 months prior to study entry
- •Recurrent PSA level elevation (between 0.4 ng/ml and 6.0 ng/ml) on two determinations at least one week apart.
- •No clinical evidence of gross local recurrence or known metastatic disease other than PSA elevation. Transrectal ultrasound and/or biopsy to evaluate local recurrence is not required. All patients will receive a bone scan and CT scan of the abdomen to exclude metastases.
- •Estimated life expectancy of at least 6 months.
- •ECOG Performance status of 0 or
- •Willing and able to give informed consent.
排除标准
- •Cryosurgery as definitive therapy of primary tumor.
- •Any metastasis.
- •No concurrent or prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- •Current systemic steroid therapy (inhaled or topical steroids acceptable).
- •Prior hormonal therapy for treatment of progressive disease.
- •Prior chemotherapy, immunotherapy, or therapy with other experimental agents for prostate cancer.
- •Any surgery within the prior 4 weeks.
- •Bilirubin and SGOT > 2 x upper limit of normal.
- •BUN and serum creatinine > 2.0 times normal.
- •No active congestive heart failure.
- •If there is a history of clinically significant obstructive airway disease, a DLCO must exceed 50%.
- •Active uncontrolled bacterial, viral or fungal infection until these conditions are corrected or controlled.
- •Any underlying medical condition which in the principal investigator's opinion will make the administration of GM-CSF hazardous or obscure the interpretation of adverse events.
- •PSA > 6.0 ng/ml
研究组 & 干预措施
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Experimental
干预措施: GM-CSF (Drug)
结局指标
主要结局
PSA Response
时间窗: Monthly
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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