Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma in Situ

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anal Cancer

Micronutrients

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Bone Density Conservation Agents

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Vitamins

Vitamin D

Cholecalciferol

Aminolevulinic Acid

Photosensitizing Agents

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

5-aminolevulinic acid hydrochloride (Gliolan), orally, 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

Total duration of drug product administration (including any open-label lead-in, if applicable).

Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

None This is a phase I dose escalation study, with two levels of light dose. The design is cohorts of 3s. Light at 50 Joules and Light at 100 joules There are pre-defined DLTs.

5-aminolevulinic acid hydrochloride (Gliolan), orally, 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT Total duration of drug product administration (including any open-label lead-in, if applicable).

Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

None This is a phase I dose escalation study, with two levels of light dose. The design is cohorts of 3s. Light at 50 Joules and Light at 100 joules There are pre-defined DLTs.

orally, 40 mg/kg 4-6 hours prior to light application

Gliolan

Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

Vitamin D3 cholecalciferol)

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.

Photodynamic Therpay

Keith Cengel, MD, PhD

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.

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

Abramson Cancer Center at Penn Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PDT Plus Vitamin D3 for Anal Dysplasia	NCT02698293	Anal Dysplasia Carcinoma in Si...	Gliolan Vitamin D3 chol... Photodynamic Th...	18 Years -	Abramson Cancer Center at Penn Medicine
PDT Plus Vitamin D3 for Anal Dysplasia	NCT02698293	Anal Dysplasia Carcinoma in Si...	Gliolan Vitamin D3 chol... Photodynamic Th...	18 Years -	Abramson Cancer Center at Penn Medicine

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