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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

Tracking Information
First Submitted Date  ICMJE March 8, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE June 14, 2017
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pomalidomide in Anal Cancer Precursors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE High Grade Squamous Intra-epithelial Lesion (HSIL)
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: Pomalidomide 2 MG Oral Capsule [Pomalyst]
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03113942
Other Study ID Numbers  ICMJE SPACE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirby Institute
Study Sponsor  ICMJE Kirby Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kirby Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP