Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

NCT ID: NCT00017485

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2007-01-31

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.

Conditions

Non-melanomatous Skin Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

HPPH

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Allan R. Oseroff, MD, PhD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RPCI-DS-95-34

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1953

Identifier Type: -

Identifier Source: secondary_id

CDR0000068696

Identifier Type: -

Identifier Source: org_study_id