Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Terminated

Phase 1

Conditions

Metastatic Cancer

Breast Cancer

Sarcoma

Lymphoma

Head and Neck Cancer

Non-melanomatous Skin Cancer

Treatments

Drug: silicon phthalocyanine 4

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00023790

CWRU1Y97

U01CA062502 (U.S. NIH Grant/Contract)

CASE-1Y97 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

NCI-T99-0007

CWRU-1Y97 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is metastatic to the skin.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.

Full description

OBJECTIVES:

Determine the maximum tolerated dose (MTD) of silicon phthalocyanine 4 (Pc 4) when administered with a fixed dose of light in patients with advanced cutaneous malignancies.
Determine the MTD of the light when administered with a fixed dose of study drug in these patients.
Determine the pharmacokinetics of Pc 4 in these patients.
Determine the clinical antitumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose (MTD) of Pc 4 is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for Pc 4 is determined, additional patients are treated with a fixed dose of Pc 4 (2 dose levels below the MTD) and escalating doses of light until the MTD is determined. The MTD of light is defined as above.

Patients are followed at 6 weeks (or 8 weeks if treated lesion on lower extremity has not healed) and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study annually.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed tumor for which no potential curative therapy exists (e.g., surgery, radiotherapy, or systemic chemotherapy)
- The following tumor types are eligible:
  - Cutaneous nodular metastatic breast carcinoma lesion with loco-regional cutaneous, soft tissue, or chest wall involvement
    - No chest wall recurrence without prior radiotherapy
    - Other metastatic sites allowed provided patient is concurrently receiving hormonal therapy or trastuzumab (Herceptin) of at least 4 weeks duration
  - Cutaneous or superficial subcutaneous nodular metastatic head and neck lesion
  - Cutaneous nodular Kaposi's sarcoma lesion
  - Stage IA-IIB or IVA cutaneous T-cell lymphoma (CTCL)
    - CTCL patches, plaques, or tumors with a surface area of up to 25 cm^2 if other areas of involved skin are blocked from therapy
  - Squamous cell or basal cell carcinoma of the skin that is not eligible for standard therapy (e.g., cryosurgery, radiotherapy, electrodesiccation and curettage, or excision)
  - Cutaneous and subcutaneous metastasis from any solid tumor (e.g., thoracic, gastrointestinal, or genitourinary cancers or sarcomas)
Bidimensionally measurable disease
- No more than 2 lesions may be treated
No single area greater than 36 cm^2 may be treated (maximum of 25 cm^2 tumor mass with a 1 cm margin)
Tumor treatable by surface (non-contact) light illumination
Skin type I-III
No tumors of the eyelids
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Male or female

Menopausal status:

Not specified

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Hemoglobin at least 9 g/dL
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
AST/ALT no greater than 2 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN
No history of hepatic cirrhosis
No hepatic disease requiring therapy

Renal:

Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance at least 50 mL/min
No renal disease requiring therapy

Cardiovascular:

No myocardial infarction within the past 6 months
No significant congestive heart failure requiring therapy
No peripheral vascular disease

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Antinuclear antibody negative
No sepsis
No prior allergic or hypersensitivity reaction to paclitaxel vehicle
No known photosensitivity diseases such as porphyria, systemic lupus erythematosus, xeroderma pigmentosum, or polymorphous light eruption
No symptomatic collagen vascular disease
Insulin-dependent or adult-onset diabetes mellitus allowed provided there are no lower extremity lesions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
At least 4 weeks since prior immunotherapy
No concurrent immunotherapy

Chemotherapy:

See Disease Characteristics
At least 4 weeks since prior systemic chemotherapy
No concurrent chemotherapy

Endocrine therapy:

See Disease Characteristics
No concurrent corticosteroids

Radiotherapy:

See Disease Characteristics
More than 4 weeks since prior radiotherapy
More than 4 weeks since prior ultraviolet B light therapy or psoralen-ultraviolet light therapy to non-study lesions/areas
No concurrent radiotherapy

Surgery:

See Disease Characteristics

Other:

At least 5 days since prior warfarin
At least 4 weeks since prior investigational drugs
At least 4 weeks since prior local therapy to study lesions
At least 6 months since prior photodynamic therapy
No concurrent aspirin, aspirin-containing medications, or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin, or cyclo-oxygenase [COX]-1 and COX-2 inhibitors)
No other concurrent photosensitizing medications such as tetracyclines, psoralens, nalidixic acid, griseofulvin, sulfa drugs, hydrochlorothiazide, furosemide, phenothiazines, or amiodarone
No concurrent therapeutic dosages of warfarin (non-therapeutic dosages allowed)