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Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-melanomatous Skin Cancer, Precancerous Condition

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Trial Information

Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Kevin Cooper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE1Y04

NCT ID:

NCT00103246

Start Date:

September 2004

Completion Date:

August 2010

Related Keywords:

  • Lymphoma
  • Non-melanomatous Skin Cancer
  • Precancerous Condition
  • 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
  • Skin Neoplasms
  • Keratosis
  • Keratosis, Actinic
  • Lymphoma
  • Mycosis Fungoides
  • Precancerous Conditions

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065