Halofuginone Hydrobromide in Treating Patients With HIV-Related Kaposi's Sarcoma

Completed · Phase 2 · Has a placebo group

Conditions studied: AIDS-related Kaposi Sarcoma, Recurrent Kaposi Sarcoma

In brief

This phase II trial studies how well halofuginone hydrobromide works in treating patients with human immunodeficiency virus (HIV)-related Kaposi's sarcoma. Halofuginone hydrobromide ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

Key facts

Study ID: NCT00064142
Run by: National Cancer Institute (NCI)
People needed: 30
Starts: 2003-05-01
Last updated by the study team: 2013-06-05

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Biopsy-proven Kaposi's sarcoma with at least 14 cutaneous lesions, 12 of which are measurable in two dimensions and can serve as marker lesions; each of the 14 lesions must measure a minimum of 0.5 cm in diameter, so that a 4 mm punch biopsy will be entirely composed of Kaposi's sarcoma
Serologic documentation of HIV infection by any of the Food and Drug Administration (FDA) approved tests
Karnofsky performance status >= 60%
Hemoglobin >= 8 g/dl
Absolute neutrophil count >= 750 cells/mm\^3
Platelet count >= 75,000/mm\^3
Creatinine < 1.5 times the upper limit of normal or creatinine clearance >= 60 mL/min
Total bilirubin should be =< 1.5 x upper limit of normal (ULN); if, however, the elevated bilirubin is felt to be secondary to indinavir therapy, patients will be allowed to enroll on protocol if the total bilirubin is =< 3.5 mg/dl provided that the direct bilirubin is normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x the upper limit of normal
Life expectancy >= 3 months
Ability and willingness to give informed consent; patients who are younger than 18 years of age will require the consent of a parent or guardian.
All women of childbearing potential must have a negative serum b human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued
Patients must, in the opinion of the investigator, be capable of complying with the protocol
Patients receiving antiretroviral therapy must be on a stable regimen for at least 12 weeks prior to study entry without showing evidence of ongoing Kaposi's sarcoma (KS) regression (ie, less than 25% decrease in the size, number or nodularity of KS lesions in the opinion of the investigator); patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND; concurrent treatment with highly active antiretroviral therapy should be strongly encouraged, in accordance with DHHS guidelines (http://www.aids-ed.org/pdfs/adult_2-4-02.pdf) but will not be required for participation

You may not qualify if…

Concurrent, acute, active, untreated opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment
Known active visceral Kaposi's sarcoma or symptomatic Kaposi's sarcoma-related edema that interferes with function or requires cytotoxic therapy
Concurrent neoplasia requiring cytotoxic therapy
Acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of study entry
Anti-neoplastic treatment for Kaposi's sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within four weeks of study entry
Previous local therapy of any KS-indicator lesion within 60 days unless the lesion has clearly progressed since treatment
Corticosteroid treatment, other than replacement doses
Use of investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols
Pregnant or breast feeding females are excluded from participation in this study since the effects of halofuginone on an unborn or young child are unknown and may potentially be toxic

Where it is running

AIDS - Associated Malignancies Clinical Trials Consortium — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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