Photodynamic Therapy, Gliolan, and Vitamin D3 for the Treatment of Carcinoma In-situ, High-Grade Anal Dyplasia, or Microinvasive Anal Cancer

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 human immunodeficiency virus (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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• 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 > 2 x 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 fluorouracil (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