Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Median Time to Treatment Termination (TTT)
研究概览
简要总结
Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.
详细描述
This is an open labeled, single arm phase II study of GM-CSF, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determine the time to treatment termination due to disease progression or toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma.
- •Patients must be asymptomatic from their cancer.
- •Patients must have evidence of recurrent carcinoma, as determined by:
- •A rising cancer antigen 125 (CA-125) serum level greater than 35 U/mL or two successive rising values with the most recent value at least 3 times the nadir value.
- •Or evidence of evaluable or measurable disease by x-ray or computed tomography (CT) scan.
- •Patients may not receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol.
- •Age > 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2.
排除标准
- •Known severe hypersensitivity to GM-CSF.
- •Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage IB endometrial carcinoma.
- •Concomitant use of anti-neoplastic therapy.
- •Treatment with a non-FDA approved or investigational drug within 30 days before Day 1 of trial treatment.
- •Any unresolved chronic toxicity greater then Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia).
- •Serum creatinine level greater than CTC grade 2 [1.5 x upper limit normal (ULN)].
- •Pregnancy or breast feeding (women of childbearing potential).
- •Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.
- •Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator.
- •Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment.
- •Patients with clinical and/or radiographic evidence of current or impending bowel obstruction.
- •Performance status <
- •Ability to understand and the willingness to sign a written informed consent document.
研究组 & 干预措施
GM-CSF, Sargramostim Cohort 1
GM-CSF, Sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
干预措施: GM-CSF, sargramostim (Drug)
GM-CSF, Sargramostim Cohort 2
GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity fora median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count.
干预措施: GM-CSF, sargramostim (Drug)
结局指标
主要结局
Median Time to Treatment Termination (TTT)
时间窗: Up to 460 days
TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.
次要结局
- Median Time to Progression (TTP)(Up to 60 months)
- Tumor Response Rate (RR)(Up to 60 months)
- Number of Participants With Adverse Events (Toxicity) Grade 3 or 4(Up to 460 days)
研究者
Richard Thomas Penson
MD
Massachusetts General Hospital