PDT Plus Vitamin D3 for Anal Dysplasia (NCT02698293) | Clinical Trial Compass
WithdrawnPhase 1
PDT Plus Vitamin D3 for Anal Dysplasia
Stopped: Covid-19
United States0Started 2019-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* A histological or cytological diagnosis of high-grade dysplasia or carcinoma in-situ, within past 4 months.
* Premalignant lesions containing focal microinvasion are eligible when:
* Surgery is not clinically mandated.
* Subjects with medical conditions precluding surgery.
* Subjects whose lesions cannot be completely resected based on size or location, or where significant functional morbidity would be anticipated with further surgery.
* Patients refuse surgery.
* The justification for inclusion of patients with microinvasive disease is based reports demonstrating the ability of photodynamic therapy to successfully treat both dysplasia and T1 squamous cell carcinoma of the anal canal
* HPV positive by Cobas or other cytological assays within past 4 months
* Documented HIV positivity
* Patients must be on highly active anti-retroviral therapy with a CD4 count \>200 for the past 12 months
* Viral load \<200 for 12 months for the past 12 months
* ECOG performance status of 0-1.
* 18 years of age or older.
* Study subjects capable of providing informed consent.
* Women of childbearing potential and men must agree to use a medically accepted method of birth control from the time they sign consent and until one month after receiving ALA
Exclusion Criteria:
* Study subjects in whom the lesion has invasive squamous cell carcinoma of the anal cavity which is clinically appreciable.
* Clinically occult microinvasive squamous cell carcinoma of the anal …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.