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

NCT ID: NCT00103246

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-08-31

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.

Conditions

Lymphoma; Non-melanomatous Skin Cancer; Precancerous Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy

Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.

Group Type: EXPERIMENTAL

silicon phthalocyanine 4

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Pc 4

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Elma Baron, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CWRU-1Y04

Identifier Type: -

Identifier Source: secondary_id

10-03-01

Identifier Type: OTHER

Identifier Source: secondary_id

CASE1Y04

Identifier Type: OTHER

Identifier Source: secondary_id

CASE1Y04

Identifier Type: -

Identifier Source: org_study_id