Clinical trial NCT00017485: Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
Official title: A Phase I Study Of Photodynamic Therapy (PDT) For The Treatment Of Basal Cell Carcinoma (BCC): A Drug/Light Dose Finding Study Utilizing 2-(1-HEXYLOXYETHYL)-2-DEVINYL PYROPHEOPHORBIDE-A (HPPH-PHOTOCLOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-melanomatous Skin Cancer
Keywords: basal cell carcinoma of the skin
recurrent skin cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer.

Detailed description: OBJECTIVES:

* Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer.
* Determine the drug dose, light dose, and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen.
* Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen.
* Determine the plasma clearance rates for HPPH in these patients.
* Determine the best combination of treatment parameters for a phase II study.

OUTLINE: This is a dose-escalation study.

Patients receive HPPH IV on day 1. Patients undergo phototherapy on days 2-3.

Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose (MED). The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity.

Patients are followed daily for 4 days, at week 1, and at months 1, 3, 6, 12, and 24.

PROJECTED ACCRUAL: A total of 4-25 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed non-morpheaform basal cell skin cancer

  * Primary disease OR
  * Recurrent disease after prior therapy (e.g., surgical excision, electrodesiccation, cryosurgery, or radiotherapy)
* At least 4 lesions, no greater than 2 cm in diameter and no greater than 5 mm in depth
* No lesions located on the eyelid, nose, ear, periauricular area, genitals, or digits, or any other lesions thought to be deep and/or aggressive

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 120,000/mm\^3

Hepatic:

* PT/PTT no greater than 1.5 times upper limit of normal (ULN)
* Bilirubin no greater than 3.0 mg/dL
* Liver enzymes no greater than 2 times ULN
* No impaired hepatic function

Renal:

* No impaired renal function

Cardiovascular:

* No myocardial infarction within the past 6 months

Other:

* No porphyria
* No known hypersensitivity to porphyrins
* No systemic lupus erythematosus
* No history of positive antinuclear antibody
* No history of degenerative disease of the retina
* No xeroderma pigmentosum
* No pancreatic disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 3 months since prior combination doxorubicin and radiotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* See Chemotherapy

Surgery:

* See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Allan R. Oseroff, MD, PhD
role: STUDY_CHAIR
References: