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- Klinische proef NCT00001911
Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections
This study will test the safety and effectiveness of a drug called interleukin-12 (IL-12) in fighting severe infectious (other than tuberculosis) caused by a group of bacteria called mycobacteria. IL-12 is similar to a substance the body produces naturally to strengthen immune function (infection-fighting ability). It works by stimulating white blood cells to increase production of a chemical called interferon gamma, which can improve or cure mycobacterial infections in some patients.
In previous studies, IL-12 has improved immune function against mycobacteria in test tube experiments and in mice. A recent study of three patients with mycobacterial infections treated with the drug showed encouraging results. The drug has also been studied more extensively in patients with cancer, HIV infection and hepatitis C.
Patients in this study will receive IL-12 injections under the skin twice a week for one year. They will be taught how to self-administer the drug, but a home care nurse or a physician may also give the injections. The drug dosage will be increased each week to determine the safest and most effective dose for fighting this infection. If intolerable side effects develop at a certain dose, the previous dose level will be used for the next injection. That dose will then be used for the rest of the study, unless unacceptable side effects develop at that level, in which case the dose will again be lowered. Patients will receive an antibiotic against mycobacteria.
Physical examinations and blood and urine tests will be done once a month for at least the first year and then every 3 months the following year to evaluate kidney, liver, and immune function. The first evaluation-at the start of the study-is done on an inpatient basis.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20892
- National Institute of Allergy and Infectious Diseases (NIAID)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Severe disseminated or pulmonary nontuberculous mycobacterial infection refractory to the best tolerated conventional therapy in addition to IFN gamma delivered for at least 3 months. This infection must have been proven by culture at some point during the illness. At the time of enrollment, patients will be eligible if they have negative cultures but histopathologic, examinable, or radiographic evidence of ongoing infection.
In vitro responsiveness to IL-12 as demonstrated by augmentation of peripheral blood mononuclear cell (PBMC) phytohemagglutinin (PHA) induced IFN gamma production.
Women of childbearing age must have a negative pregnancy test (urine or serum) at the time of starting the study and agree to take measures to avoid pregnancy throughout the study while receiving IL-12. Males will be advised that the effects of IL-12 on sperm are not well-known, and they should avoid conception during the study period.
Age 18 years or over.
Adequate hematopoietic, renal and hepatic function, defined as:
Absolute neutrophil count greater than or equal to 1000/microL (G-CSF permitted);
Hemoglobin greater than or equal to 9 g/dl (transfusion or erythropoietin permitted);
Platelet count greater than or equal to 100,000/microL;
Creatinine less than or equal to 1.5 X upper limit of normal;
Bilirubin less than or equal to 1.5 X upper limit of normal;
AST/SGOT less than or equal to 2.5 X upper limit of normal;
ALT/SGPT less than or equal to 2.5 X upper limit of normal;
Calculated Creatinine Clearance greater than 60 mL/min.
Karnofsky Performance Status index greater than or equal to 70.
Written signed informed consent.
No HIV infection.
No active malignancy.
No symptomatic cardiac disease or ongoing treatment for same.
No active seizure disorder or ongoing treatment for same.
No pregnancy or lactation.
No surgery during the two weeks prior to the start of IL-12.
No concurrent use of systematic corticosteroids, except for physiologic replacement.
No exposure to any investigational drug within four weeks prior to the start of dosing.
No gastrointestinal bleeding or uncontrolled peptic ulcer disease.
No history of inflammatory bowel disease or autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus.
No other major illness which, in the investigator's judgement, will substantially increase the risk associated with the patient's participation in this study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Altare F, Durandy A, Lammas D, Emile JF, Lamhamedi S, Le Deist F, Drysdale P, Jouanguy E, Doffinger R, Bernaudin F, Jeppsson O, Gollob JA, Meinl E, Segal AW, Fischer A, Kumararatne D, Casanova JL. Impairment of mycobacterial immunity in human interleukin-12 receptor deficiency. Science. 1998 May 29;280(5368):1432-5. doi: 10.1126/science.280.5368.1432.
- Altare F, Lammas D, Revy P, Jouanguy E, Doffinger R, Lamhamedi S, Drysdale P, Scheel-Toellner D, Girdlestone J, Darbyshire P, Wadhwa M, Dockrell H, Salmon M, Fischer A, Durandy A, Casanova JL, Kumararatne DS. Inherited interleukin 12 deficiency in a child with bacille Calmette-Guerin and Salmonella enteritidis disseminated infection. J Clin Invest. 1998 Dec 15;102(12):2035-40. doi: 10.1172/JCI4950.
- Chan SH, Perussia B, Gupta JW, Kobayashi M, Pospisil M, Young HA, Wolf SF, Young D, Clark SC, Trinchieri G. Induction of interferon gamma production by natural killer cell stimulatory factor: characterization of the responder cells and synergy with other inducers. J Exp Med. 1991 Apr 1;173(4):869-79. doi: 10.1084/jem.173.4.869.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekte attributen
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Gram-positieve bacteriële infecties
- Actinomycetales-infecties
- Infecties
- Overdraagbare ziekten
- Mycobacterium-infecties
- Mycobacterium-infecties, niet-tuberculeus
- Fysiologische effecten van medicijnen
- Antineoplastische middelen
- Immunologische factoren
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Adjuvantia, immunologisch
- Interleukine-12
Andere studie-ID-nummers
- 990147
- 99-I-0147
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Atypical Mycobacterium Infection
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Oregon Health and Science UniversityNational Institute of Allergy and Infectious Diseases (NIAID); National Heart... en andere medewerkersWervingMycobacterium Avium-complexVerenigde Staten
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Kevin WinthropPatient-Centered Outcomes Research Institute; Medical University of South Carolina en andere medewerkersWervingMycobacterium Avium-complex | Niet-tuberculeuze Mycobacterium-infectieVerenigde Staten, Canada
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Yale UniversityVoltooidInfectie, Mycobacterium Avium-Intracellulare
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Radboud University Medical CenterWervingMycobacterium Avium Complexe longziekteKorea, republiek van, Verenigde Staten, Kroatië, Japan, Nederland
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Johns Hopkins UniversityWervingMycobacterium Avium-complexVerenigde Staten
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National Institute of Allergy and Infectious Diseases...VoltooidMycobacterium Avium-intracellulaire infectieVerenigde Staten
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Mayo ClinicVoltooidMycobacterium Avium intracellulair complex (MAC)Verenigde Staten
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University of FloridaIngetrokkenBijwerkingen | Mycobacterium Avium-complex
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Radboud University Medical CenterWervingMycobacterium Avium Complexe longziekteNederland
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Shanghai Pulmonary Hospital, Shanghai, ChinaKarolinska Institutet; Fudan University; University of Sydney; Shanghai Municipal...WervingGram-positieve bacteriële infecties | Mycobacterium-infecties | Mycobacterium Avium-intracellulaire infectie | Mycobacterium Avium-complexChina
Klinische onderzoeken op Interleukine-12
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Centre Chirurgical Marie LannelongueOnbekend
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United States Naval Medical Center, San DiegoCEL-SCI CorporationBeëindigd
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VA Office of Research and DevelopmentBaltimore VA Medical Center; South Texas Veterans Health Care SystemNog niet aan het wervenObesitas | Post-COVID-voorwaardenVerenigde Staten
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Jenny Craig, Inc.VoltooidTijdbeperkte voedingVerenigde Staten
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Stanford UniversityActief, niet wervend
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VA Office of Research and DevelopmentNog niet aan het wervenDiabetische voetzweerVerenigde Staten
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University of FloridaNational Institute on Aging (NIA)Werving
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Afyonkarahisar Health Sciences UniversityActief, niet wervend
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University of North Carolina, Chapel HillDuke University; Blue Cross Blue Shield of North Carolina; UNC Health AllianceActief, niet wervend
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University of ManitobaVoltooid