The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma
NCT ID: NCT00001114
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2000-03-31
Brief Summary
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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.
Detailed Description
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Up to 90 patients are randomized to receive either low or high doses of IFN-alpha (1 or 10 million Units/day) in combination with a fixed dose of ddI. Fourteen patients are initially entered at each dose level. If no objective antitumor responses are observed among the first 14 patients at a given dose, no further patients are entered on that treatment arm. If one or more antitumor responses are seen at a given dose, up to 45 patients may be entered on that treatment arm. Patients must complete at least 4 weeks of study therapy to be considered evaluable for tumor response. Treatment is continued until tumor progression or unacceptable toxicity occurs. PER AMENDMENT 9/19/96: NOTE - After 16 weeks of treatment subjects may receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Interferon alfa-2b
Didanosine
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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:
* Prior IFN-alpha.
* Corticosteroids, biological response modifiers, cytotoxic chemotherapy, or known neurotoxic drugs (other than ddI or ddC) within 30 days prior to study entry.
* Therapy with antiretroviral drugs (other than ddI) within 7 days prior to study entry.
Prior Treatment:
Excluded:
* Radiation therapy within 30 days prior to study entry.
Risk Behavior:
* Alcohol consumption is strongly discouraged.
* Patients considered to be noncompliant should be excluded.
12 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Krown SE
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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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.
Other Identifiers
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11183
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 206
Identifier Type: -
Identifier Source: org_study_id