The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma
A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma
2 other identifiers
interventional
90
2 countries
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Schering-Ploughcollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (13)
Stanford CRS
Palo Alto, California, 94115, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Puerto Rico-AIDS CRS
San Juan, 00936, Puerto Rico
Related Publications (1)
Krown SE, Li P, Von Roenn JH, Paredes J, Huang J, Testa MA. Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: a randomized phase II AIDS clinical trials group study. J Interferon Cytokine Res. 2002 Mar;22(3):295-303. doi: 10.1089/107999002753675712.
PMID: 12034036BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Krown SE