Clinical trial · Interventional
Study of Pomalidomide in Anal Cancer Precursors
Study of Pomalidomide in Anal Cancer Precursors (SPACE): a Phase 2 Study of Immunomodulation in People With Persistent HPV-associated High Grade Squamous Intraepithelial Lesions
NCT03113942CI-TRIAL-00057419SPACEunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Squamous Intra-epithelial Lesion (HSIL) | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pomalidomide 2 MG Oral Capsule [Pomalyst] | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pomalidomide group
- description
- 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).
- interventionNames
- Drug: Pomalidomide 2 MG Oral Capsule [Pomalyst]
Primary outcomes (1)
- measure
- Histological High Grade Squamous Intraepithelial Lesions (HSIL) clearance at 6 months of therapy
- timeFrame
- 6 months
- description
- Histological high grade squamous intra-epithelial lesion clearance
Secondary outcomes (3)
- measure
- incidence of grade 3 and 4 adverse events and therapy delays (tolerability)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (26)
- BACKGROUNDMunoz 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. PMID 16949995
- BACKGROUNDParkin 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. PMID 16949997
- BACKGROUNDWorld Health Organization International Agency for Reseach on Cancer. IARC Monograph on the Evaluation of Carcinogenic Risks to Humans: Volume 90, Human Papillomavirus. World Health Organization, Geneva 2007.
- BACKGROUNDMachalek DA, Poynten M, Jin F, Fairley CK, Farnsworth A, Garland SM, Hillman RJ, Petoumenos K, Roberts J, Tabrizi SN, Templeton DJ, Grulich AE. Anal human papillomavirus infection and associated neoplastic lesions in men who have sex with men: a systematic review and meta-analysis. Lancet Oncol. 2012 May;13(5):487-500. doi: 10.1016/S1470-2045(12)70080-3. Epub 2012 Mar 23. PMID 22445259
- BACKGROUNDPalefsky JM. Anal cancer prevention in HIV-positive men and women. Curr Opin Oncol. 2009 Sep;21(5):433-8. doi: 10.1097/CCO.0b013e32832f511a. PMID 19587592
- BACKGROUNDGrulich AE, Poynten IM, Machalek DA, Jin F, Templeton DJ, Hillman RJ. The epidemiology of anal cancer. Sex Health. 2012 Dec;9(6):504-8. doi: 10.1071/SH12070. PMID 22958581
- BACKGROUNDPetoumenos K, van Leuwen MT, Vajdic CM, Woolley I, Chuah J, Templeton DJ, Grulich AE, Law MG; Australian HIV Observational Database. Cancer, immunodeficiency and antiretroviral treatment: results from the Australian HIV Observational Database (AHOD). HIV Med. 2013 Feb;14(2):77-84. doi: 10.1111/j.1468-1293.2012.01038.x. Epub 2012 Aug 30. PMID 22934689
- Yarchoan R, Tosato G, Little RF. Therapy insight: AIDS-related malignancies--the influence of antiviral therapy on pathogenesis and management. Nat Clin Pract Oncol. 2005 Aug;2(8):406-15; quiz 423. doi: 10.1038/ncponc0253.