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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014