Study of Pomalidomide in Anal Cancer Precursors | NCT03113942

NCT03113942

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pomalidomide group	Experimental	Open label - all participants will receive pomalidomide 2mg orally once a day for 6 cycles (21 days on treatment and a 7 day rest period constitutes a cycle).	Drug: Pomalidomide 2 MG Oral Capsule [Pomalyst]

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pomalidomide 2 MG Oral Capsule [Pomalyst]	Drug	Pomalidomide is an oral immunomodulatory derivative of thalidomide. Thalidomide and its derivatives are small molecules with broad effects on immune activation, including T-cell activation and responsiveness. Pomalidomide augments T cell responsiveness and proliferation by several mechanisms, many mediated by transcriptional regulation downstream of its primary target, cereblon. Effects include increased production of IL-2 and interferon-γ (IFN-γ), enhanced CD4+ and CD8+ T cell co-stimulation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histological High Grade Squamous Intraepithelial Lesions (HSIL) clearance at 6 months of therapy	Histological high grade squamous intra-epithelial lesion clearance	6 months

Secondary Outcomes

Measure	Description	Time Frame
incidence of grade 3 and 4 adverse events and therapy delays (tolerability)	incidence of grade 3 and 4 adverse events and therapy delays (tolerability)	6 months
number of subjects completing of full six month course

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
No history of thromboembolic disease
No evidence of anal cancer or Superficially Invasive Squamous Cell Carcinoma of the Anus (SISCCA)
Willingness to use appropriate contraception (including refraining from sperm donation)
Age 18 years or older
Provision of written informed consent

In addition, for subjects with HIV:
Adherence to a stable suppressive antiretroviral therapy (ART) regimen, unchanged for at least two months
CD4+ count ≥ 200 cells/µl
HIV viral load < 200 copies/mL for at least six months

Exclusion Criteria:

Absolute neutrophil count (ANC) <1000 cells/μL
Haemoglobin <10.0 g/dL
Platelet count <75,000 cells/μL
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > three times upper limit of normal
Calculated or measured creatinine clearance (CLCr) ≤ 50 mL/min (calculated by Cockcroft-Gault formula)
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
Current pregnancy or breastfeeding
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

PubMed Identifier	Type	Citation	Retractions
16949995	Background	Munoz N, Castellsague X, Berrington de Gonzalez A, Gissmann L. Chapter 1: HPV in the etiology of human cancer. Vaccine. 2006 Aug 31;24 Suppl 3:S3/1-10. doi: 10.1016/j.vaccine.2006.05.115. Epub 2006 Jun 23.
16949997	Background	Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006 Aug 31;24 Suppl 3:S3/11-25. doi: 10.1016/j.vaccine.2006.05.111.