Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients are followed daily for 4 days, at week 1, and at months 1, 3, 6, 12, and 24. PROJECTED ACCRUAL: A total of 4-25 patients will be accrued for this study.

Official Title
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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)

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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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: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 120,000/mm^3 Hepatic: 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 Renal: No impaired renal function Cardiovascular: No myocardial infarction within the past 6 months Other: 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 Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HPPH|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma of the skin, recurrent skin cancer