Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer - Full Text View

Sponsor:	Roswell Park Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00017485

Purpose

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.

Condition	Intervention	Phase
Non-melanomatous Skin Cancer	Drug: HPPH	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Enrollment:	6
Study Start Date:	January 2000
Study Completion Date:	January 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017485

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Allan R. Oseroff, MD, PhD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Alan Oseroff, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00017485 History of Changes
Other Study ID Numbers:	CDR0000068696, P30CA016056, RPCI-DS-95-34, NCI-G01-1953
Study First Received:	June 6, 2001
Last Updated:	March 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

basal cell carcinoma of the skin
recurrent skin cancer

Additional relevant MeSH terms:

Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms by Site
Neoplasms
Skin Diseases

Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on February 12, 2012