A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
Collecte de données
Astrocytome+16
+ Maladies du cerveau
+ Néoplasmes cérébraux
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine. Secondary * Determine the progression-free survival of patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before every odd course. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study.
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.18 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.De 18 à 120 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 confirmed malignant glioma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Anaplastic mixed oligoastrocytoma * Progressive or recurrent disease\* after radiotherapy with or without chemotherapy NOTE: \*Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible * Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * Transaminases ≤ 4 times upper limit of normal Renal * Creatinine ≤ 1.7 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment * No concurrent serious infection * No other concurrent medical illness that would preclude study treatment * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior thalidomide * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No prior procarbazine * No more than 2 prior chemotherapy regimens for malignant glioma Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy Other * Recovered from prior therapy * More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors) * No concurrent antidepressants * No other concurrent investigational agents
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs 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 5 sites
CCOP - Southeast Cancer Control Consortium
Goldsboro, United StatesWake Forest University Comprehensive Cancer Center
Winston-Salem, United StatesCCOP - Greenville
Greenville, United States