Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

NCT00017485 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000068696P30CA016056RPCI-DS-95-34NCI-G01-1953
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin; recurrent skin cancer

Interventions

HPPH DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Allan R. Oseroff, MD, PhD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2000
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

US (1)