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

NCT00103246 | Completed Phase 1 DMC

• 4 other identifiers: CASE1Y04P30CA043703CASE-CWRU-1Y0410-03-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Non-melanomatous Skin Cancer; Precancerous Condition

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy

EXPERIMENTAL

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

Drug: silicon phthalocyanine 4

Interventions

silicon phthalocyanine 4 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.

Also known as: Pc 4

Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lymphoma; Precancerous Conditions; Skin Neoplasms; Carcinoma, Basal Cell; Mycosis Fungoides; Sezary Syndrome; Keratosis, Actinic; Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Keratosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: September 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2010
• Last Updated: January 22, 2019

Record last verified: 2011-01

Locations

US (1)