The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection. Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function. Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha.

Key facts

Study ID

NCT00001114

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

90

Expected to finish

2000-03-01

Last updated by the study team

2021-11-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Chemoprophylaxis for candidiasis and herpes simplex.
• Up to 14 days of metronidazole.
• Recombinant erythropoietin.
• G-CSF (for severe cases of neutropenia).
• Isoniazid for treatment of TB if given in conjunction with pyridoxine.
• Required in patients with CD4 counts < 200 cells/mm3:
• Prophylaxis for PCP.
• PER AMENDMENT 9/19/96:
• After the first 16 weeks of combined IFN alpha-2b and ddI treatment subjects may at the discretion of the investigator receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
• Patients must have:
• Positive antibody to HIV.
• Biopsy-proven Kaposi's sarcoma (at least 5 measurable lesions, with at least 1 measurable cutaneous lesion) involving the skin, lymph nodes, oral cavity, or asymptomatic lesions of the GI tract not requiring systemic chemotherapy. Lung involvement with Kaposi's sarcoma excludes.
• Consent of parent or guardian if less than 18 years of age.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Concurrent opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
• Visceral (non-nodal) Kaposi's sarcoma requiring cytotoxic chemotherapy.
• Severe (> 2+) tumor-associated edema.
• Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial neoplasia.
• Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
• Significant symptomatic cardiac disease.
• Medical contraindication.
• Concurrent Medication:
• Excluded:
• Other investigational, antiviral, immunomodulating, or antitumor agents.
• Drugs associated with peripheral neuropathy (other than ddI).
• PER AMENDMENT 9/19/96:
• Other antiretroviral agents may not be taken during the first 16 weeks of combined IFN alpha-2b and ddI treatment.
• Concurrent Treatment:
• Excluded:
• Radiation therapy.
• Patients with the following prior conditions are excluded:
• Opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
• Prior grade 3 or 4 toxicity attributed to ddI therapy.
• Prior history of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
• History of myocardial infarction or ventricular arrhythmias.
• Prior Medication:
• Excluded:

Where it is running

• Stanford CRS — Palo Alto, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Ctr. — New York, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Puerto Rico-AIDS CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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