Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

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Brief Title

Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

Official Title

A Randomized, Phase III Study of Intra-anal Imiquimod 2.5% vs. Topical 5-fluorouracil 5% vs. Observation for the Treatment of High-grade Anal Squamous Intraepithelial Lesions in HIV-infected Men and Women

Brief Summary

      This randomized phase III trial studies imiquimod or fluorouracil to see how well they work
      compared to observation in treating patients with high-grade anal squamous skin lesions who
      are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may
      stimulate the immune system in different ways and stop tumor cells from growing. Drugs used
      in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. It is not yet known
      whether imiquimod or fluorouracil is more effective than observation in treating high-grade
      anal squamous skin lesions.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the efficacy of intra-anal imiquimod 2.5% for treatment of anal high-grade
      squamous intraepithelial lesions (HSIL) compared to observation only.

      II. To assess the efficacy of intra-anal topical 5-fluorouracil (fluorouracil) 5% for
      treatment of anal HSIL compared to observation only.

      SECONDARY OBJECTIVES:

      I. To assess the safety and tolerability of intra-anal imiquimod 2.5% and topical
      5-fluorouracil 5%.

      II. To compare the efficacy of intra-anal imiquimod 2.5% and topical 5-fluorouracil 5%.

      III. To assess for partial response of intra-anal imiquimod 2.5% or topical 5-fluorouracil 5%
      as compared to observation only.

      IV. To evaluate the effect of intra-anal imiquimod 2.5% and topical 5-fluorouracil 5% on
      human papilloma virus (HPV) persistence.

      V. To evaluate anal HSIL outcomes at week 44. VI. To evaluate the effect of behavioral
      patterns including tobacco smoking and sexual activity on treatment efficacy, tolerability
      and HPV.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

      ARM A: Patients apply imiquimod intra-anally once daily (QD) for 16 weeks.

      ARM B: Patients apply fluorouracil intra-anally twice daily (BID) on days 1-5. Treatment
      repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable
      toxicity.

      ARM C: Patients receive no treatment. Patients who still have HSIL at week 20 and who agree
      to randomization may cross-over to Arm A or B.

      After completion of study treatment, patients are followed up at weeks 20, 24, 26, 32, 40,
      and 44.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of participants achieving complete response (Arm A and B)

Secondary Outcome

 Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Condition

Anal Intraepithelial Neoplasia

Intervention

imiquimod

Study Arms / Comparison Groups

 Arm A (imiquimod)
Description:  Patients apply imiquimod intra-anally QD for 16 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

September 2015

Completion Date

April 2022

Primary Completion Date

July 2021

Eligibility Criteria

        Inclusion Criteria:

          -  HIV-positive; documentation of HIV infection must be based on a federally approved,
             licensed HIV test performed in conjunction with screening (enzyme linked immunosorbent
             assay [ELISA], western blot, or other test); alternatively, this documentation may
             include a record that another physician has documented that the patient has HIV based
             on prior ELISA and western blot; an approved antibody test will be used to confirm
             diagnosis; if the physician is treating a patient with combination antiretroviral
             therapy (cART) with a history of HIV positivity based on an approved antibody test
             then repeat antibody confirmation is not necessary

          -  Biopsy-proven HSIL (anal intraepithelial neoplasia 2 (AIN2) and/or AIN3) of the anal
             canal at either the squamocolumnar junction or distal anus, documented within 60 days
             prior to enrollment, but not less than 1 week prior to enrollment

          -  HSIL occupies at least 25% of the circumference of the anal canal at either the
             squamocolumnar junction or distal anus on high-resolution anoscopy (HRA) at screening
             or entry based on available biopsy results and visual appearance

          -  Anal HSIL lesions are visible at study entry and no lesions are suspicious for
             invasive cancer

          -  Ability to understand and willing to provide informed consent

          -  Participants must, in the opinion of the Investigator, be capable of complying with
             the requirements of this protocol including self-administration of study treatment

          -  Karnofsky performance status of >= 70%

          -  Cluster of differentiation (CD)4 count >= 200 within 120 days prior to enrollment or
             plasma HIV-1 ribonucleic acid (RNA) < 200 copies/mL within 120 days prior to
             enrollment

          -  For females, cervical cytology (if having a cervix) and gynecologic evaluation within
             12 months prior to enrollment

          -  Absolute neutrophil count (ANC) > 750 cells/mm^3 within 90 days prior to enrollment

          -  Hemoglobin >= 9.0 g/dL within 90 days prior to enrollment

          -  Platelet count >= 75,000/mm^3 within 90 days prior to enrollment

        Exclusion Criteria:

          -  History of anal cancer

          -  Prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% at
             any point, or use of perianal imiquimod 2.5%, 3.75% or 5% or topical 5-fluorouracil 5%
             within 6 months prior to enrollment

          -  Extensive concurrent perianal or lower vulvar HSIL or condyloma requiring a different
             treatment modality than the study treatment, or treatment that cannot be deferred in
             observation arm, per examining provider

          -  Condyloma occupying more than 50% of the circumference of the anal canal or that
             obscures a satisfactory exam

          -  Ongoing use of anticoagulant therapy other than aspirin or nonsteroidal
             anti-inflammatory drugs (NSAIDs)

          -  Acute treatment for an infection (excluding fungal infection of the skin and sexually
             transmitted infections) or other serious medical illness within 14 days prior to study
             entry

          -  Malignancy requiring systemic therapy; note: Kaposi's sarcoma limited to the skin is
             not exclusionary unless requiring systemic chemotherapy

          -  Concurrent systemic corticosteroids, cytokines, and immunomodulatory therapy (e.g.
             interferons)

          -  Prior history of HPV vaccination

          -  Treatment for anal or perianal HSIL, low-grade squamous intraepithelial lesion (LSIL)
             or condyloma within 4 months of entry; please note that infrared coagulation (IRC) or
             electrocautery of a biopsy site to stop bleeding does not constitute treatment

          -  Female participants who are pregnant or breastfeeding; women of childbearing potential
             must have a negative urine or serum pregnancy test within 72 hours prior to initiating
             study treatment; all women of childbearing potential must be willing to comply with an
             acceptable birth control regimen to prevent pregnancy while receiving treatment and
             for 3 months after treatment is discontinued as determined by the Investigator;
             post-menopausal women must be amenorrheic for at least 12 months to be considered of
             non-childbearing potential; (note: a woman of childbearing potential is one who is
             biologically capable of becoming pregnant; this includes women who are using
             contraceptives or whose sexual partners are either sterile or using contraceptives)
      

Gender

All

Ages

25 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Timothy Wilkin, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT02059499

Organization ID

AMC-088

Secondary IDs

NCI-2013-02288

Responsible Party

Sponsor

Study Sponsor

AIDS Malignancy Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Timothy Wilkin, Principal Investigator, AIDS Associated Malignancies Clinical Trials Consortium


Verification Date

February 2021