NCT00453050已完成1 期
Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Toxicity and tolerability by CTCAE version 3.0
研究概览
简要总结
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared laser therapy with or without indocyanine green in patients with stage III or IV melanoma and cutaneous metastases.
- Determine the complete systemic and local response rates in patients treated with this regimen.
Secondary
- Determine the effect of this treatment on immunologic parameters in these patients.
研究设计
- 研究类型
- Interventional
- 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 confirmed melanoma meeting the following criteria:
- •Stage III or IV disease
- •Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed
- •Presence of 1 or more cutaneous metastases ≤ 3 cm in size
- •Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness
- •No uncontrolled brain metastases
- •Treated brain metastases that are stable for 3 months allowed at the investigator's discretion
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 4 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study completion
- •No known allergy to any drugs used during study treatment
- •No unstable medical illness
- •Not immunosuppressed
- •Patients immunosuppressed due to disease (e.g., HIV positive) allowed
- •PRIOR CONCURRENT THERAPY:
- •No systemic steroids or any other immunosuppressive medications within the past month
- •No chemotherapy within the past 4 weeks
- •No radiotherapy to the treatment site within the past 4 weeks
- •Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed
- •No concurrent immunosuppressive agents
排除标准
- 未提供
结局指标
主要结局
Toxicity and tolerability by CTCAE version 3.0
Complete systemic and local response rates at 16 months
次要结局
- Immunologic parameters
研究者
研究点 (1)
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