Lymphoma, Non-melanomatous Skin Cancer, Precancerous Condition
Conditions
Keywords
skin cancer, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, recurrent skin cancer, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, actinic keratosis, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma
Brief summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis, Bowen's disease, squamous cell or basal cell skin cancer, or stage IA, IB, IIA, or IIB mycosis fungoides. * Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants . * Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these participants. * Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these participants. OUTLINE: This is a dose-escalation study. Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present). Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. Three additional participants are treated at the MTD. After completion of study therapy, participants are followed for up to 2 weeks. PROJECTED ACCRUAL: A total of 16-45 participants will be accrued for this study.
Interventions
Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Actinic keratosis * Bowen's disease * Squamous cell skin cancer * Basal cell skin cancer * Clinical stage IA, IB, IIA, or IIB mycosis fungoides * Fitzpatrick skin type I-IV PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patient must use effective contraception * No diabetes mellitus * No known hypersensitivity to ethanol or propylene glycol * No significant history of photosensitivity, including diagnosis of any of the following: * Porphyria * Lupus erythematosus * Xeroderma pigmentosum * Severe polymorphous light eruption * Solar urticaria PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 2 weeks since prior anticancer radiotherapy * No concurrent radiotherapy Surgery * Lesions must be healed after prior biopsy Other * More than 2 weeks since prior topical, local, or systemic anticancer therapy * More than 2 weeks since prior anticancer phototherapy * More than 2 weeks since prior photosensitizing medications, including any of the following: * Tetracyclines * Quinolones * Psoralens * Hydrochlorothiazide * Furosemide * Trimethoprim-sulfamethoxazole * Griseofulvin * Nalidixic acid * Amiodarone * Phenothiazines * High-dose nonsteroidal anti-inflammatory drugs * No other concurrent photosensitizing medications * No concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | Treatment repeats weekly for up to 3 weeks. Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. |
| Local toxicity as measured by physical exam and punch biopsy | at 24 hours and 2 weeks after the start of study treatment |
| Treatment efficacy as measured by physical exam and punch biopsy | at 24 hours and 2 weeks after the start of study treatment |
| Systemic photosensitivity as measured by minimum erythema dose (MED) testing | at 2, 24, and 48 hours after completion of photodynamic therapy |
Countries
United States
Outcome results
None listed