PDT Plus Vitamin D3 for Anal Dysplasia
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | April 1, 2019 |
| End Date: | April 1, 2021 |
| Contact: | Sally McNulty, RN |
| Email: | Sally.McNulty@uphs.upenn.edu |
| Phone: | 215-662-7720 |
A Phase I Study of Photodynamic Therapy (PDT) Plus Vitamin D3 for High-grade Anal Dysplasia and Microinvasive Anal Cancer
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.
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.
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 cavity which is
not focal.
- Study subjects who are pregnant or lactating .
- Study subjects who have a platelet count of less than 100,000/cubic mm.
- Study subjects with elevated aspartate aminotransferase (AST), alanine
aminotransferase (ALT), alkaline phosphatase, or total bilirubin levels >2X normal or
a history of chronic liver disease or cirrhosis of the liver.
- Significant cardiovascular history that would put the study subject at risk from
hypotension that may occur with ALA
- Study subjects with porphyria or hypersensitivity to porphyrins.
- Administration of the following compounds: tetracyclines, sulfonamides,
fluoroquinolones within 48 hours, or hypericin extracts within a week prior to light
administration.
- Study subjects with abnormal baseline creatinine level or diagnosed kidney disease.
- Treatment with 5-FU, Imiquimod, trichloroacetic acid or ablative therapy within the
previous month.
- Study subjects who have a medical history of immune suppression. This will include
patients with a past transplantation requiring ongoing immunosuppressive medications.
- A history of sarcoidosis, hyperphosphatemia, or known kidney stones
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Edgar Ben-Josef, MD
Phone: 215-662-7720
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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