Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.

In the Phase I portion of the study, 20 patients per site each receive isotretinoin in escalating doses. If a patient experiences grade 2 or worse toxicity (o...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • PCP prophylaxis (required for patients with CD4 count \< 200 cells/mm3).
• • Chemoprophylaxis for candidiasis and herpes simplex.
• • Metronidazole for up to 14 days.
• • Erythropoietin.
• Patients must have:
• • HIV seropositivity.
• • NO active opportunistic infection requiring treatment with prohibited drugs.
• • Phase I - Current grade 1 AIN (i.e., low grade SIL) OR treated or untreated grade 2 or 3 AIN (i.e., high grade SIL).
• • Phase II - Prior histologically confirmed grade 2 or 3 AIN / high grade SIL, with ablative therapy within the past 30-90 days.
• • Capability of complying with study protocol.
• NOTE:
• • The terms condyloma, grade 1 AIN, and low grade SIL are interchangeable. Grade 2 or 3 AIN is interchangeable with high grade SIL.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Active medical problems for which the patient is undergoing evaluations or for which prohibited therapy is required.
• • Other active malignancies requiring systemic therapy.
• • Significant symptomatic cardiac disease.
• NOTE:
• • Patients with malignancies being managed with local therapy (e.g., Kaposi's sarcoma, basal cell carcinoma) may enroll at the discretion of the site investigator.
• Concurrent Medication:
• Excluded:
• • G-CSF (filgrastim).
• • Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).
• • Corticosteroids.
• • Biologic response modifiers.
• • Cytotoxic chemotherapy.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy.
• Patients with the following prior conditions are excluded:
• • History of ventricular arrhythmias or myocardial infarction.
• Prior Medication:
• Excluded within 20 days prior to study entry:
• • G-CSF (filgrastim).
• • Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).
• • Corticosteroids.
• • Biologic response modifiers.
• • Cytotoxic chemotherapy.
• Prior Treatment:
• Excluded within 20 days prior to study entry:
• • Radiation therapy.
• Excluded within 14 days prior to study entry:
• • Transfusion.
• • Active substance abuse or illegal drug use (alcohol consumption is strongly discouraged).