Expired Study
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Seattle, Washington 98122


Purpose:

PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. 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.


Study 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 (or grade 3 or worse hypertriglyceridemia), dose is reduced to the previously tolerated dose for the remainder of the 6 week period. Patients are then reassessed for anal neoplasia; those with no progression and no grade 2 or worse toxicity receive an additional 6 weeks of isotretinoin in combination with interferon alfa-2a. For Phase II of the study, a separate group of patients who have undergone ablative therapy are randomized to one of three arms (26 patients/arm): isotretinoin alone at the dose tolerated by at least 60 percent of patients in Phase I; isotretinoin plus interferon alfa-2a; or observation only. Treatment continues for 48 weeks.


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).


NCT ID:

NCT00000764


Primary Contact:

Study Chair
Palefsky JM


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98122
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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