Study of Pomalidomide in Anal Cancer Precursors
Study of Pomalidomide in Anal Cancer Precursors
This is a single centre open label phase II trial to determine the antitumor efficacy of the
 oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated
 high grade squamous intra-epithelial lesions (HSIL) in patients with and without human
 immunodeficiency virus (HIV) infection.
Inclusion Criteria:

 1. Persistent high grade squamous intra-epithelial lesion (HSIL) which must meet all of
 the following criteria:

 i. Pathologically confirmed grade 2 or 3 AIN demonstrated by high resolution anoscopy
 with grade on each occasion re-confirmed at screening by nominated study pathologist
 from Douglas Hanly Moir (DHM) (pathology case review to be conducted prior to
 enrolment) ii. Lesion must have been visualised on at least three sequential occasions
 over at least 12 months, including the pre enrolment screening high resolution
 anoscopy (HRA).

 iii. Lesion must have persistent geographical characteristics consistent with a single
 lesion observed over time (as defined in the Manual of Operations).

 2. No history of thromboembolic disease

 3. No evidence of anal cancer or Superficially Invasive Squamous Cell Carcinoma of the
 Anus (SISCCA)

 4. Willingness to use appropriate contraception (including refraining from sperm
 donation)

 5. Age 18 years or older

 6. Provision of written informed consent

 In addition, for subjects with HIV:

 7. Adherence to a stable suppressive antiretroviral therapy (ART) regimen, unchanged for
 at least two months

 8. CD4+ count ≥ 200 cells/µl

 9. HIV viral load < 200 copies/mL for at least six months

 Exclusion Criteria:

 1. Absolute neutrophil count (ANC) <1000 cells/μL

 2. Haemoglobin <10.0 g/dL

 3. Platelet count <75,000 cells/μL

 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > three times upper
 limit of normal

 5. Calculated or measured creatinine clearance (CLCr) ≤ 50 mL/min (calculated by
 Cockcroft-Gault formula)

 6. Patients with significant cardiac dysfunction including congestive heart failure, NY
 Heart Association Class II; Myocardial infarction within 12 months of starting study;
 unstable of poorly controlled angina

 7. Current pregnancy or breastfeeding

 8. Any condition not already outlined above which, in the opinion of the clinical
 investigator, would place the subject at risk if they participated or would jeopardise
 adherence or follow up