Terminé

Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

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Ce qui est testé

Doxorubicin hydrochloride (liposomal)

+ Filgrastim
+ Bleomycin sulfate
Médicament
Qui peut participer

Sarcoma, Kaposi

+ HIV Infections
À partir de 18 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 17 avril 2012
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia. AS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.

Titre officielComparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 17 avril 2012
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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.
Détails du design
120 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
Sarcoma, Kaposi
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * G-CSF. * Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ). * PCP prophylaxis (required if CD4 count \< 200 cells/mm3). * Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex. * Up to 14 days of metronidazole. * Recombinant erythropoietin. Patients must have: * Documented HIV infection. * Advanced stage Kaposi's sarcoma. * No active acute opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Significant pulmonary insufficiency (unless due to pulmonary KS). * Significant cardiac insufficiency. * Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer. * Grade 2 or worse peripheral neuropathy. * Altered mental status that prevents informed consent. * Active Mycobacterium tuberculosis. * Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF). Concurrent Medication: Excluded: * GM-CSF. * Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine). * Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair). Concurrent Treatment: Excluded: * Radiation therapy to study marker lesions. Patients with the following prior condition are excluded: * Neuropsychiatric history. Prior Medication: Excluded: * Any anti-KS therapy within 21 days prior to study entry. * Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin. * Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry. PER AMENDMENT 11/29/95: * No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.



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 17 sites
Suspendu
Alabama Therapeutics CRSBirmingham, United StatesVoir le site
Suspendu
USC CRSLos Angeles, United States
Suspendu
UCLA CARE Center CRSLos Angeles, United States
Suspendu
Ucsf Aids CrsSan Francisco, United States

Terminé17 Centres d'Étude