Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients
tanespimycin
+ laboratory biomarker analysis
Mélanome+8
+ Néoplasmes germinaux et embryonnaires
+ Néoplasmes par type histologique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2004
Date à laquelle le premier participant a commencé l'étude.PRIMARY OBJECTIVES: I. Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses. II. Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases and/or downstream proteins such as phospho-ERK, CDK4 and cyclin D1. III. Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor. OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no). Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
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.50 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: * Histologically or cytologically confirmed melanoma * Stage III or IV disease * No primary melanoma of the choroid or mucosa * Measurable disease * At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan * Tumor amenable to biopsy (for the first 10 patients in each stratum only) * Patients must have measurable disease in addition to the tumor(s) to be biopsied * No brain or epidural metastases * Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for \>= 6 months * Performance status - Karnofsky 60-100% * Performance status - ECOG 0-2 * More than 3 months * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * WBC \>= 3,000/mm\^3 * AST and ALT =\< 2.5 times upper limit of normal * Creatinine normal * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No history of myocardial infarction * No history of prolonged QTc interval * No active ischemic heart disease within the past 12 months * No uncontrolled dysrhythmia or dysrhythmias requiring medication * No congenital prolonged QT syndrome * No left bundle branch block * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) * No prior serious allergic reaction to eggs * No other uncontrolled illness * No active or ongoing infection requiring systemic antimicrobial treatment * No psychiatric illness or social situation that would preclude study compliance * No more than 1 prior chemotherapy regimen for metastatic melanoma * Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior radiotherapy dose =\< 3,000 cGy to fields including substantial marrow * More than 4 weeks since prior radiotherapy and recovered * No prior radiotherapy field that included the heart (e.g., mantle) * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent medications that may prolong the QTc interval * No other concurrent anticancer therapy * No other concurrent investigational agents * No concurrent treatment with any of the following medications or herbal remedies: * Inhibitors of CYP3A4: * Fluconazole * Itraconazole * Ketoconazole * Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin) * Midazolam * Nifedipine * Verapamil * Diltiazem * Terfenadine * Cyclosporine * Cisapride * Inducers of CYP3A4: * Carbamazepine * Phenobarbital * Phenytoin * Rifampin * Herbal extracts and tinctures with CYP3A4 inhibitory activity: * Hydrastis canadensis (goldenseal) * Hypericum perforatum (St. John's wort) * Uncaria tomentosa (cat's claw) * Echinacea angustifolia roots * Trifolium pratense (wild cherry) * Matricaria chamomilla (chamomile) * Glycyrrhiza glabra (licorice) * Dillapiol * Hypericin * Naringin * No other concurrent herbal extracts
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
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