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)
18 Years
N/A
Both
Non-melanomatous Skin Cancer
Trial Information
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)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Allan R. Oseroff, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068696
NCT ID:
NCT00017485
Start Date:
January 2000
Completion Date:
January 2007
Related Keywords:
- Non-melanomatous Skin Cancer
- basal cell carcinoma of the skin
- recurrent skin cancer
- Skin Neoplasms
- Carcinoma, Basal Cell
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
