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Study of Pomalidomide in Anal Cancer Precursors (SPACE)

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ClinicalTrials.gov Identifier: NCT03113942
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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
High Grade Squamous Intra-epithelial Lesion (HSIL) Drug: Pomalidomide 2 MG Oral Capsule [Pomalyst] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open 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 : June 14, 2017
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113942


Locations
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Australia, New South Wales
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Kirby Institute
Publications:
World 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.
Polizzotto MN, Sereti I, Uldrick TS, et al. Pomalidomide induces expansion of activated and central memory CD4 and CD8 T-cells in vivo in patients with and without HIV infection. American Society of Hematology Annual Meeting, San Francisco 2014.
POMALYST® (pomalidomide) capsules Product Information. Department of Health Therapeutic Goods Administration (TGA) April 2016. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf accessed 23 Nov 2016.

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT03113942    
Other Study ID Numbers: SPACE
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anus Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Thalidomide
Pomalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents