Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
carmustine
+ topotecan hydrochloride
Maladies du cerveau+5
+ Maladies du système nerveux central
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine. Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma. OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week. Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional 3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients. Patients are evaluated after every 6 week cycle. PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
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.36 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
DISEASE CHARACTERISTICS: Histologically proven recurrent primary malignant glioma Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky at least 60% Hematopoietic: Hematocrit greater than 29% ANC greater than 1,500/mm^3 Platelet count greater than 125,000/mm^3 Hepatic: SGOT less than 1.5 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL BUN less than 25 mg/dL Other: Not pregnant Effective contraceptive method must be used for the duration of the study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 6 weeks of study No prior topotecan or carmustine treatment failure No more than 1 prior chemotherapy regimen Endocrine therapy: Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level Radiotherapy: No prior radiotherapy within 6 weeks of study Surgery: No prior surgical resection within 3 weeks of study Other: No concurrent medication that may interfere with study results
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 2 sites
Duke Comprehensive Cancer Center
Durham, United StatesOuvrir Duke Comprehensive Cancer Center dans Google MapsSaint Jude Children's Research Hospital
Memphis, United States