NCT02698293

PDT Plus Vitamin D3 for Anal Dysplasia

A Phase I Study of Photodynamic Therapy (PDT) Plus Vitamin D3 for High-grade Anal Dysplasia and Microinvasive Anal Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anal Dysplasia
• Carcinoma in Situ

Interventions

Type	Name	Description
DRUG	Gliolan	orally, 40 mg/kg 4-6 hours prior to light application
DRUG	Vitamin D3 cholecalciferol)	Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.
OTHER	Photodynamic Therpay	Approximately 4-6 hours after photosensitizer administration, activating light will be applied. The target mucosal lesion will be identified based on the initial clinical evaluation. Treatment light will be generated using a Modulight ML7710-630-6K diode laser, This laser produces up to 6W total power, with a peak wavelength of 630nm and 90% of laser power within 630-633 nm. The light fluence (doses) will be 50 and 100 Joules per square centimeter.

Timeline

• Start date: 2019-12-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2016-03-03
• Last updated: 2022-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study