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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00103246
First received: February 7, 2005
Last updated: January 19, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: silicon phthalocyanine 4
    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.
    Other Name: Pc 4
Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103246

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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 April 16, 2014