A Phase I Study Of Photodynamic Therapy (PDT) For The Treatment Of Basal Cell Carcinoma (BCC): A Drug/Light Dose Finding Study Utilizing 2-(1-HEXYLOXYETHYL)-2-DEVINYL PYROPHEOPHORBIDE-A (HPPH-PHOTOCLOR)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer.
详细描述
OBJECTIVES:
- Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer.
- Determine the drug dose, light dose, and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen.
- Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen.
- Determine the plasma clearance rates for HPPH in these patients.
- Determine the best combination of treatment parameters for a phase II study.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH IV on day 1. Patients undergo phototherapy on days 2-3.
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose (MED). The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 non-morpheaform basal cell skin cancer
- •Primary disease OR
- •Recurrent disease after prior therapy (e.g., surgical excision, electrodesiccation, cryosurgery, or radiotherapy)
- •At least 4 lesions, no greater than 2 cm in diameter and no greater than 5 mm in depth
- •No lesions located on the eyelid, nose, ear, periauricular area, genitals, or digits, or any other lesions thought to be deep and/or aggressive
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 2,000/mm^3
- •Platelet count at least 120,000/mm^3
- •PT/PTT no greater than 1.5 times upper limit of normal (ULN)
- •Bilirubin no greater than 3.0 mg/dL
- •Liver enzymes no greater than 2 times ULN
- •No impaired hepatic function
- •No impaired renal function
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No porphyria
- •No known hypersensitivity to porphyrins
- •No systemic lupus erythematosus
- •No history of positive antinuclear antibody
- •No history of degenerative disease of the retina
- •No xeroderma pigmentosum
- •No pancreatic disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 3 months since prior combination doxorubicin and radiotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •See Chemotherapy
- •See Disease Characteristics
排除标准
- 未提供