Terminé

A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma

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Ce qui est testé

Bleomycin sulfate

+ Vincristine sulfate
+ Doxorubicin hydrochloride
Médicament
Qui peut participer

Sarcoma, Kaposi

+ HIV Infections
À partir de 13 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 29 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections. AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections. In Phase I, eligible patients with advanced Kaposi's sarcoma are randomly assigned to either ddI or ddC in combination with DBV chemotherapy. On the average, patients receive 12-44 weeks of combined chemotherapy and antiretroviral therapy. If vincristine is deleted from Phase I because of excess neurotoxicity, it will not be administered as part of the combination chemotherapy if that treatment is continued in the Phase II study. The Phase II trial proceeds when at least six cycles (12 weeks) of DBV have been completed by six patients enrolled in Phase I, and an overall evaluation of tolerance to each combination treatment plan has been completed. Study medication is administered as in Phase I, with the possible deletion of vincristine. All patients who complete DBV chemotherapy with complete or partial response or stable disease will continue to receive the originally assigned investigational antiretroviral drug (ddC or ddI) for an additional 24 weeks.

Titre officielPhase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 29 octobre 2021
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
72 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 13 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: Required: * Prophylaxis for Pneumocystis carinii pneumonia for all patients with CD4 cell counts \< 200 cells/mm3. Allowed: * Chemoprophylaxis for candidiasis, MAC, and herpes simplex. * Up to 14-day courses of metronidazole. * Recombinant erythropoietin. * Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony stimulating factor (G-CSF) for patients with ANC \< 1000 cells/mm3. * Isoniazid for treatment of tuberculosis, with permission of the protocol chair, when given in conjunction with pyridoxine. Patients must have: * HIV infection. * Kaposi's sarcoma. For patients \< 18 years of age: * consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Opportunistic infection requiring treatment with myelosuppressive antibiotics (unless on G-CSF or GM-CSF). * Other active malignancies except basal cell carcinoma of the skin or in situ cervical carcinoma. * Prior history or current clinical evidence of peripheral neuropathy (= or \> grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not controlled by antiseizure medication. * Significant pulmonary insufficiency (exertional dyspnea with minimal exertion, except that due to pulmonary Kaposi's sarcoma) or cardiac insufficiency (New York Heart Association status \> 2). * Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol. Concurrent Medication: Excluded: * Myelosuppressive antibiotics (unless on G-CSF or GM-CSF). * Investigational agents other than drugs available on treatment IND and used for FDA sanctioned indications, or other antiviral, immunomodulating or antitumor drugs. * Drugs associated with peripheral neuropathy (other than ddI, ddC, or vincristine), including hydralazine, disulfiram, nitrofurantoin, cisplatin, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide. Patients with the following prior conditions or symptoms are excluded: * Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol. Prior Medication: Excluded: * Systemic treatment with doxorubicin, bleomycin, or vincristine. * Antitumor (Kaposi's sarcoma) drugs within 7 days of study entry. * Any investigational drug (other than drugs available on treatment IND and used for FDA sanctioned indications) within 14 days of study entry. * Neurotoxic drugs (other than ddI or ddC) within 30 days of study entry. * Intralesional injections to a Kaposi's sarcoma marker lesion within 30 days of study entry. Prior Treatment: Excluded: * Irradiation of a Kaposi's sarcoma marker lesion within 30 days of study entry. Alcohol consumption is strongly discouraged.



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 14 sites
Suspendu
USC CRSLos Angeles, United StatesVoir le site
Suspendu
UCLA CARE Center CRSLos Angeles, United States
Suspendu
Ucsf Aids CrsSan Francisco, United States
Suspendu
University of Colorado Hospital CRSAurora, United States

Terminé14 Centres d'Étude