Phase 2 N=180 Treatment

Photodynamic Therapy in Treating Patients With Skin Cancer

Non-melanomatous Skin Cancer · Precancerous Condition

Bottom Line

View on ClinicalTrials.gov: NCT00002975 ↗

Enrolled (actual)

180

Serious AEs

—

Results posted

Oct 2013

Primary outcome: Primary: Response Rate

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: aminolevulinic acid (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Roswell Park Cancer Institute
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Response Rate	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00002975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.