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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103246
• Other study ID #: CASE1Y04
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 1
• Start date: September 2004
• Est. completion date: August 2010

Study information

• Verified date: January 2011
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Keratosis, Actinic
• Lymphoma
• Mycoses
• Mycosis Fungoides
• Non-melanomatous Skin Cancer
• Precancerous Condition
• Precancerous Conditions
• Skin Neoplasms

Intervention

Drug:
• silicon phthalocyanine 4
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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Local toxicity as measured by physical exam and punch biopsy		at 24 hours and 2 weeks after the start of study treatment
Primary	Treatment efficacy as measured by physical exam and punch biopsy		at 24 hours and 2 weeks after the start of study treatment
Primary	Systemic photosensitivity as measured by minimum erythema dose (MED) testing		at 2, 24, and 48 hours after completion of photodynamic therapy