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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

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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 InstituteBuffalo, New York  14263