Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	CWRU-1Y97 NCI-T99-0007, NCT00023790, T99-0007, CASE-1Y97

Objectives

1. 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.
2. Determine the MTD of the light when administered with a fixed dose of study drug in these patients.
3. Determine the pharmacokinetics of Pc 4 in these patients.
4. Determine the clinical antitumor response in patients treated with this regimen.

Entry 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 cm² 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 cm² may be treated (maximum of 25 cm² 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

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)

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/mm³
• Hemoglobin at least 9 g/dL
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Toxicity as assessed by physical exam and laboratory data weekly for 4 weeks and in week 6
Disease response as measured by skin assessment and photography weekly for 4 weeks and in week 6

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Scot Remick, MD, Protocol chair		Ph: 216-844-5412

Registry Information
Official Title		Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies
Trial Start Date		2001-08-24
Trial Completion Date		2006-02-08
Registered in ClinicalTrials.gov		NCT00023790
Date Submitted to PDQ		2001-07-06
Information Last Verified		2006-01-19
NCI Grant/Contract Number		CA43703, CA62502

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