Etoposide par voie orale à faible dose pour le traitement du sarcome de Kaposi lié au SIDA en rechute ou en progression
Cette étude vise à évaluer l'efficacité de l'Etoposide oral à faible dose en tant que traitement pour les individus atteints de sarcome de Kaposi lié au SIDA qui a soit récidivé soit progressé.
Etoposide
Infections transmises par le sang+21
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time. Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.
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.41 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 12 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 Concurrent Medication: Allowed: Maintenance therapy for opportunistic infections. Patients must have: HIV infection. Kaposi's sarcoma that has relapsed or progressed. Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions). NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted). Consent of parent or guardian if less than 18 years of age. NOTE: This study is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix. Grade 3 or worse peripheral neuropathy. Altered mental status that would prevent informed consent or prevent study compliance. Patients with the following prior condition are excluded: Neuropsychiatric history. Prior Medication: Excluded: Prior etoposide. Any other anti-KS drugs within 14 days prior to study entry. Any investigational drug other than antiretrovirals within 14 days prior to study entry. Any prior investigational agent, if given as the ONLY prior treatment for KS. Prior Treatment: Excluded: Radiation therapy within 7 days prior to study entry. Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.
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 20 sites
Univ of Alabama at Birmingham
Birmingham, United StatesOuvrir Univ of Alabama at Birmingham dans Google MapsK Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, United StatesUniv of Southern California / LA County USC Med Ctr
Los Angeles, United StatesSan Francisco Gen Hosp
San Francisco, United States