Clinical trial NCT00103246: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-02-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: OBJECTIVES:

* Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants 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 participants .
* Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these participants.
* Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these participants.

OUTLINE: This is a dose-escalation study.

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. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. Three additional participants are treated at the MTD.

After completion of study therapy, participants are followed for up to 2 weeks.

PROJECTED ACCRUAL: A total of 16-45 participants will be accrued for this study.

Eligibility 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

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 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.
measure: Local toxicity as measured by physical exam and punch biopsy
timeFrame: at 24 hours and 2 weeks after the start of study treatment
measure: Treatment efficacy as measured by physical exam and punch biopsy
timeFrame: at 24 hours and 2 weeks after the start of study treatment
measure: Systemic photosensitivity as measured by minimum erythema dose (MED) testing
timeFrame: at 2, 24, and 48 hours after completion of photodynamic therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Kevin Cooper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Elma Baron, MD
role: PRINCIPAL_INVESTIGATOR
References: