Study of Pomalidomide in Anal Cancer Precursors (SPACE)

March 28, 2022 updated by: Kirby Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Pomalyst
  • pomalidomide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of grade 3 and 4 adverse events and therapy delays (tolerability)
Time Frame: 6 months
incidence of grade 3 and 4 adverse events and therapy delays (tolerability)
6 months
number of subjects completing of full six month course
Time Frame: 6 months
number of subjects completing of full six month course (feasibility of polidamide in this setting)
6 months
effect of pomalidomide on self-reported health related quality of life and cancer anxiety during and after therapy
Time Frame: 6 months
individual patient change in quality of life questionnaire (SF12) from baseline to mid therapy and end therapy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

March 31, 2019

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPACE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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