Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
filgrastim
+ therapeutic allogeneic lymphocytes
+ cyclophosphamide
Maladies génito-urinaires+22
+ Adénocarcinome
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma. Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population. Determine the efficacy of this treatment regimen in terms of tumor regression, response duration, progression free survival, and overall survival in these patients. Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response. OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15 minutes beginning on day 0 and continuing until the target cells are collected. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover. If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation, patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes. Patients may receive an additional course of donor T lymphocytes at the investigator's discretion. Patients are followed at days 30 and 100, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5 years.
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.19 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 65 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 metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI Measurable disease by radiography must be reproducible Bony disease or effusions not measurable No active CNS disease currently receiving radiotherapy or steroids No effusion or ascites of more than 1 liter prior to drainage HLA 5/6 or 6/6 matched sibling donor available No known hypersensitivity to E. coli derived products No active infection No health condition that would preclude donation PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 g/dL No active hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF at least 50% Pulmonary: DLCO at least 50% of predicted Other: No active infection HIV negative No psychological problem that would preclude study compliance No known hypersensitivity to E. coli derived products Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior systemic chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics
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
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
University of Chicago Cancer Research Center
Chicago, United StatesOuvrir University of Chicago Cancer Research Center dans Google Maps