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
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Purpose
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 patients with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Non-melanomatous Skin Cancer Precancerous Condition |
Drug: silicon phthalocyanine 4 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions |
- Maximum tolerated dose [ Time Frame: Treatment repeats weekly for up to 3 weeks. Cohorts of 3 patients receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. ] [ Designated as safety issue: Yes ]
- Local toxicity as measured by physical exam and punch biopsy [ Time Frame: at 24 hours and 2 weeks after the start of study treatment ] [ Designated as safety issue: Yes ]
- Treatment efficacy as measured by physical exam and punch biopsy [ Time Frame: at 24 hours and 2 weeks after the start of study treatment ] [ Designated as safety issue: No ]
- Systemic photosensitivity as measured by minimum erythema dose (MED) testing [ Time Frame: at 2, 24, and 48 hours after completion of photodynamic therapy ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | September 2004 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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Drug: silicon phthalocyanine 4
OBJECTIVES:
- Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in patients 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 patients.
- Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these patients.
- Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive topical silicon phthalocyanine 4 (Pc 4). One hour later, patients 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 patients 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 patients experiences dose-limiting toxicity. Three additional patients are treated at the MTD.
After completion of study therapy, patients are followed for up to 2 weeks.
PROJECTED ACCRUAL: A total of 16-45 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Principal Investigator: | Kevin Cooper, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
| Principal Investigator: | Elma Baron, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Elma D. Baron, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00103246 History of Changes |
| Other Study ID Numbers: | CASE1Y04, P30CA043703, CASE-CWRU-1Y04, 10-03-01, CASE1Y04 |
| Study First Received: | February 7, 2005 |
| Last Updated: | January 19, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Case Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Skin Neoplasms Keratosis Keratosis, Actinic Lymphoma Mycosis Fungoides Precancerous Conditions Neoplasms by Site Neoplasms Skin Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous |
Lymphoma, T-Cell Lymphoma, Non-Hodgkin Silicon Phthalocyanine Silicon phthalocyanine Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Radiation-Sensitizing Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013