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Photosensitizer

Vitamin D3 cholecalciferol) for Carcinoma

Phase 1
Waitlist Available
Led By Keith Cengel, MD, PhD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is testing whether a cancer treatment called photodynamic therapy, which uses a light-sensitive drug and low-dose laser light, is safe and effective for people with precancerous tumors or early-stage anal cancer.

Eligible Conditions
  • Carcinoma
  • Anal Intraepithelial Neoplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment3 Interventions
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.
Group II: Cohort 2Experimental Treatment3 Interventions
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.
Group III: Cohort 1Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aminolevulinic acid
FDA approved

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,664 Total Patients Enrolled
24 Trials studying Carcinoma
897 Patients Enrolled for Carcinoma
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,064 Total Patients Enrolled
23 Trials studying Carcinoma
882 Patients Enrolled for Carcinoma
Keith Cengel, MD, PhDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
3 Previous Clinical Trials
111 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PDT Plus Vitamin D3 for Anal Dysplasia
2019. "PDT Plus Vitamin D3 for Anal Dysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02698293.
~0 spots leftby Apr 2025
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