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

Active:	No
Cancer Type:	Anal Cancer Unknown Primary	NCT ID:	NCT02059499
Trial Phases:	Phase III	Protocol IDs:	AMC-088 (primary) NCI-2013-02288 AMC-088
Eligibility:	21 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AIDS Malignancy Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT02059499

Summary

This 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions.

Objectives

PRIMARY OBJECTIVES:
I. Complete response defined as no anal biopsies with high-grade squamous intraepithelial lesions (HSIL) and cytology without HSIL at Week 20.
II. To assess the efficacy of intra-anal topical fluorouracil (5FU) for treatment of anal HSIL compared to observation only.

SECONDARY OBJECTIVES:
I.To describe the efficacy of intra-anal imiquimod 2.5% for treatment of anal HSIL compared to observation only.
II. To assess the safety and tolerability of intra-anal imiquimod 2.5% and topical 5FU.
III. To compare the efficacy of intra-anal imiquimod 2.5% and topical 5FU.
IV. To assess for partial response of intra-anal imiquimod 2.5% or topical 5FU as compared to observation only.
V. To evaluate the effect of intra-anal imiquimod 2.5% and topical 5FU on human papilloma virus (HPV) persistence.
VI. To evaluate anal HSIL outcomes at Week 44.
VII. 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. Perianal disease is also treated if present.

ARM B: Patients apply fluorouracil intra-anally twice daily (BID) on days 1-5. Treatment repeats every 2 Weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. Perianal disease is also treated if present.

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.

Patients undergo blood sample collection during screening and biopsy throughout the study.

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

Treatment Sites in Georgia

Georgia Cancer Center for Excellence at Grady
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
404-489-9000
www.gradyhealth.org

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