This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of
patients with pre-malignant tumors and superficial microinvasive disease of the anal canal
and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer ALA
orally followed by the administration of red light (629-635 nm) to the tumor from a laser.
The dose of ALA will be 40 mg/kg administered approximately 4-6 hours before light
administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in
each. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3
days prior through 14 weeks after light delivery for PDT. Patients will be observed for 30
days for the development of DLT. Patients will be followed up for 24 months for additional
toxicity and efficacy data collection.
Phase:
Phase 1
Details
Lead Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins