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SPACE: Study of Pomalidomide in Anal Cancer Precursors

Sponsor
Kirby Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03113942
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
66.6
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pomalidomide 2 MG Oral Capsule [Pomalyst]
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label, phase 2 trial, single-armOpen label, phase 2 trial, single-arm
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 14, 2017
Actual Primary Completion Date :
Mar 31, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pomalidomide group

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]
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.
Other Names:
  • pomalidomide
  • Pomalyst

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Histological High Grade Squamous Intraepithelial Lesions (HSIL) clearance at 6 months of therapy [6 months]

      Histological high grade squamous intra-epithelial lesion clearance

    Secondary Outcome Measures

    1. incidence of grade 3 and 4 adverse events and therapy delays (tolerability) [6 months]

      incidence of grade 3 and 4 adverse events and therapy delays (tolerability)

    2. number of subjects completing of full six month course [6 months]

      number of subjects completing of full six month course (feasibility of polidamide in this setting)

    3. effect of pomalidomide on self-reported health related quality of life and cancer anxiety during and after therapy [6 months]

      individual patient change in quality of life questionnaire (SF12) from baseline to mid therapy and end therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Persistent high grade squamous intra-epithelial lesion (HSIL) which must meet all of the following criteria:
    1. 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).
    1. Lesion must have persistent geographical characteristics consistent with a single lesion observed over time (as defined in the Manual of Operations).

    1. No history of thromboembolic disease

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

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

    4. Age 18 years or older

    5. Provision of written informed consent

    In addition, for subjects with HIV:

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

    2. CD4+ count ≥ 200 cells/µl

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Vincent's Hospital Darlinghurst New South Wales Australia 2010

    Sponsors and Collaborators

    • Kirby Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kirby Institute
    ClinicalTrials.gov Identifier:
    NCT03113942
    Other Study ID Numbers:
    • SPACE
    First Posted:
    Apr 14, 2017
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anus Neoplasms
    Thalidomide
    Pomalidomide

    Study Results

    No Results Posted as of Mar 31, 2022