Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This phase I trial is studying the side effects and best dose of interleukin-12 and interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer cells.
详细描述
OBJECTIVES:
I. Determine the toxicity of interleukin-12 and interferon alfa in patients with metastatic renal cell carcinoma or malignant melanoma.
II. Determine the maximum tolerated dose of these drugs when concurrently administered in this patient population.
III. Obtain preliminary data on the antitumor efficacy of this combination in these patients.
OUTLINE: This is a dose-escalation study, followed by a randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed renal cell carcinoma or malignant melanoma
- •Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
- •Bidimensionally measurable of evaluable disease
- •No significant effusions and/or ascites
- •No more than 3 prior regimens for metastatic disease
- •No known CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.5 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •ALT/AST no greater than 3 times upper limit of normal
- •Creatinine no greater than 1.8 mg/dL
- •Calcium no greater than 11.5 mg/dL
- •Cardiovascular:
- •No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
- •No congestive heart failure
- •No angina pectoris
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active peptic ulcer
- •No autoimmune disease
- •No inflammatory bowel disease
- •No local or systemic infections requiring IV antibiotics within the past 28 days
- •No known seizure disorder
- •No other prior malignancy except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any curatively treated malignancy in complete remission for at least 3 years
- •HIV, hepatitis B surface antigen, and hepatitis C negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Recovered from prior biologic therapy
- •Chemotherapy:
- •Recovered from prior chemotherapy
- •Endocrine therapy:
- •At least 28 days since prior hormonal therapy and recovered
- •No concurrent corticosteroids except for replacement steroids
- •Radiotherapy:
- •Recovered from prior radiotherapy
- •At least 28 days since prior radiotherapy for control of pain from skeletal lesions
- •At least 28 days since prior major surgery requiring general anesthesia
- •No organ allografts
- •No concurrent aspirin
- •No concurrent barbiturates
- 另有 1 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients receive interferon alfa SC three times a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
干预措施: recombinant interleukin-12 (Biological)
Arm III
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above.
干预措施: recombinant interleukin-12 (Biological)
Arm III
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above.
干预措施: recombinant interferon alfa (Biological)
Arm II
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients receive interferon alfa SC three times a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
干预措施: recombinant interferon alfa (Biological)
Arm I
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients receive interleukin-12 SC twice a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
干预措施: recombinant interleukin-12 (Biological)
Arm I
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients receive interleukin-12 SC twice a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
干预措施: recombinant interferon alfa (Biological)