NCT00028652终止1 期
Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.
详细描述
OBJECTIVES:
- Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases.
- Determine the antitumor immune response in patients treated with this regimen.
- Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients.
- Compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks.
OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). Patients are assigned to 1 of 2 treatment arms.
- Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5.
- Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12.
Patients with stable or responding disease may receive 1 subsequent course beginning on day 29.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid malignancy
- •Surgically or medically incurable disease
- •No standard chemotherapy or radiotherapy exists for this disease
- •Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin
- •Cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes that are easily palpable
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 80,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •Creatinine less than 2.0 mg/dL
- •HIV negative
- •No active infections requiring antibiotic, antiviral, or antifungal treatment
- •No other active malignancy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 month since prior immunotherapy
- •No concurrent colony-stimulating factors
- •Chemotherapy:
- •See Disease Characteristics
- •At least 1 month since prior chemotherapy
- •Endocrine therapy:
- •At least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent)
- •No concurrent steroids
- •Radiotherapy:
- •See Disease Characteristics
- •Prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease
- •See Disease Characteristics
- •No prior organ allografts
- •No other concurrent antineoplastic therapy
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (2)
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