Photodynamic Therapy in Treating Patients With Skin Cancer

NCT00002975 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000065494RPCI-DS-96-55NCI-G97-1224
• Study Type: interventional
• Target: 180
• 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. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

Conditions

Non-melanomatous Skin Cancer; Precancerous Condition

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin; actinic keratosis

Outcome Measures

Primary Outcomes (1)

• Response Rate

  One Year

Study Arms (1)

PDT

EXPERIMENTAL

4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation

Drug: aminolevulinic acid

Interventions

aminolevulinic acid DRUG

PDT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Actinic keratoses * Histologically proven superficial or nodular basal cell carcinoma (BCC), squamous cell carcinoma in situ (Bowen's disease), or microinvasive squamous cell carcinoma * No nodular BCC greater than 4 mm thick that will not be surgically removed * No carcinoma with uncertain margins requiring Moh's surgery PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No known photosensitivity disease * No porphyria or hypersensitivity to porphyrins PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior treatment with systemic photosensitizer that would cause residual cutaneous photosensitivity during study participation

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

Precancerous Conditions; Carcinoma, Basal Cell; Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study was activated prior to RPCI putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI died and left incomplete data. Efficay and safety data were not analyzed.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Nathalie Zeitouni, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1997
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: October 10, 2013
• Results First Posted: October 10, 2013

Record last verified: 2013-08

Locations

US (1)