A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
Interferon alfa-2a
+ Zidovudine
+ Interferon alfa-n1
Infections transmises par le sang+21
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted. Patients are randomized to receive IFN-A or IFN-A2A (given by intramuscular injection) and combined with AZT (taken orally) daily for 8 weeks. Study stops when maximum tolerated dose (MTD) is reached. Two cohorts of 4 patients enter each dose level. Patients do not enter into the next dose level until all patients have completed 3 weeks of treatment. AZT will escalate only if there is no unacceptable toxicity (grade 2 in = or > 3 patients or > grade 2 in any patient), subsequent increases in IFN-A or IFN-A2A will be permitted, but the AZT dose will remain fixed. The MTD for a given IFN-A or IFN-A2A dose level is defined as grade 2 toxicity (grade 3 for hemoglobin, neutrophil count, or SGOT) in 4 of the 6 patients. Patients have blood drawn every week and their general health is evaluated. Pharmacokinetic studies will be done on days 1, 21, and 24. Patients tolerating the combination may be continued on the same dose level for 1 year except if patient has reached complete remission for = or > 90 days, IFN-A or IFN-A2A will decrease to 3 times a week.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.56 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma. Evidence of HIV infection as manifested by a positive antibody test. Exclusion Criteria Active drug or alcohol abuse. Co-existing Condition: Excluded are patients with: Active opportunistic infections requiring ongoing therapy. Excluded within 90 days of study entry: Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. Concurrent neoplasms other than basal cell carcinoma of the skin. Known hypersensitivity to polymycin B or neomycin. Excluded are patients with: Active opportunistic infections requiring ongoing therapy. Excluded within 90 days of study entry: Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. Concurrent neoplasms other than basal cell carcinoma of the skin. Known hypersensitivity to polymycin B or neomycin. Prior Medication: Excluded: Interferon. Zidovudine (AZT). Excluded within 30 days of study entry: Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents. Other drugs which can cause neutropenia or significant nephrotoxicity. Rifampin or rifampin derivatives, or systemic anti-infectives. Excluded within 90 days of study entry: Other antiviral agents. A history of Pneumocystis carinii pneumonia (PCP) completed treatment. Prior Treatment: Excluded within 30 days of study entry: Radiation therapy.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Univ of Miami School of Medicine
Miami, United StatesOuvrir Univ of Miami School of Medicine dans Google Maps