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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:
National Cancer Institute (NCI)
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
History of Changes

February 7, 2005
January 19, 2011
September 2004
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
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Complete list of historical versions of study NCT00103246 on ClinicalTrials.gov Archive Site
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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
Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Non-melanomatous Skin Cancer
  • Precancerous Condition
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
August 2010
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103246
CASE1Y04, P30CA043703, CASE-CWRU-1Y04, 10-03-01, CASE1Y04
Yes
Elma D. Baron, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
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
Case Comprehensive Cancer Center
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP