Clinical trial · Interventional
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-melanomatous Skin Cancer | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| silicon phthalocyanine 4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy
- description
- Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.
- interventionNames
- Drug: silicon phthalocyanine 4
Primary outcomes (4)
- measure
- Maximum tolerated dose
- timeFrame
- 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.
- measure
- Local toxicity as measured by physical exam and punch biopsy
- timeFrame
- at 24 hours and 2 weeks after the start of study treatment
- measure
- Treatment efficacy as measured by physical exam and punch biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available