NCT00445523已完成2 期
A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Interferon Alfa (IFN-α) on Patients With Advanced or Metastatic Renal Cell 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
- 28
- 试验地点
- 1
- 主要终点
- Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
研究概览
简要总结
Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax® will delay tumor progression.
详细描述
Patients with metastatic renal cell cancer will be enrolled in the study if all inclusion/exclusion criteria are met. Once the patient is enrolled, and baseline tests have been completed, the patient will start treatment.
Trovax® alone arm:
Trovax will be given as an intramuscular injection every two weeks for the first two months, then once a month for the next 2 months, and then once every 2 months for up to a year.
Trovax® plus IFN-α:
Trovax® schedule will be the same as the Trovax® alone arm. IFN will be given on the first, third and fifth day of the week for a total of twelve weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Locally advanced or metastatic histologically confirmed clear cell or papillary cell renal carcinoma.
- •Primary tumor surgically removed.
- •Stable or progressive disease as defined by RECIST criteria.
- •Age ≥ 18 years.
- •At least one prior standard of care therapy (IL-2, IFN-α, or approved kinase inhibitor)
- •At least four weeks from prior use of standard of care therapy.
- •Karnofsky performance status ≥ 80%.
- •Corrected Serum Calcium ≥ 10 g/dL.
- •Patients on stable doses of bisphosphonates (Fosamax, Actonel, Didrocal) that show subsequent tumor progression may continue on this medication; however patients are not allowed to start bisphosphonates within one month prior to starting trial, or throughout the duration of the trial.
- •Major surgery or radiation therapy completed ≥ 4 weeks prior to treatment.
- •Clinically immunocompetent.
- •Free of clinically apparent autoimmune disease.
- •Absolute lymphocyte count ≥ 500/μL, Absolute neutrophil count ≥ 1200/μL, Platelet count ≥ 100,000/μl, Hemoglobin ≥ 9mg/dL.
- •No evidence of active ischemia on Electrocardiogram (ECG)
- •Women must be either post-menopausal, rendered surgically sterile, or using reliable form of contraceptive.
- •Able to give informed consent and comply with the protocol.
排除标准
- •Prior treatment with TroVax®
- •No supplements of complementary medicines/botanicals are permitted during study, except for any combination of the following: multivitamins, selenium, lycopene, soy supplements, Vitamin E.
- •Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
- •Participation in any other clinical trial within 30 days.
- •Cerebral metastasis on MRI Scan.
- •Currently active second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse.
- •Serious intercurrent infections or nonmalignant medical illnesses which are uncontrolled.
- •Psychiatric illnesses that would limit compliance with protocol.
- •A history of psychosis or clinical depression.
- •Liver function tests (ALT, AST) more than 1.5 X upper limit of normal (ULN). Bilirubin must be within normal limits.
- •Creatinine ≥ 1.5 X ULN.
- •Known allergy to egg proteins.
- •Known allergy to neomycin.
- •History of allergic response to previous vaccinia vaccinations.
- •Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
- •Positive for HIV or Hepatitis B or C.
- •Clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%.
- •Pregnancy or lactation
- •Current chemotherapy, immunotherapy, radiation therapy, or the requirement for radiotherapy.
- •No investigational or commercial agents or therapies other that those included in the protocol treatment may be administered with the intent to treat malignancy.
研究组 & 干预措施
1
Experimental
TroVax® alone
干预措施: TroVax® (Immunological Vaccine Therapy) (Biological)
2
Experimental
TroVax® plus IFN-α
干预措施: TroVax® (Immunological Vaccine Therapy) (Biological)
2
Experimental
TroVax® plus IFN-α
干预措施: Interferon-alpha (Drug)
结局指标
主要结局
Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
时间窗: restaging every 9 weeks
次要结局
- Overall survival(restaging every 9 weeks)
- Time to Progression(restaging every 9 weeks)
- Progression-free survival(restaging every 9 weeks)
研究者
研究点 (1)
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