Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
recombinant interferon alfa
+ dexamethasone
Amyloïdose+17
+ Troubles des Protéines Sanguines
+ Maladies Cardiovasculaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasone/interferon alfa. Identify prognostic factors that may relate to response and overall survival in these patients. Evaluate the qualitative and quantitative toxic effects of this regimen. OUTLINE: Patients are stratified by prior amyloidosis treatment (yes vs no). All patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20 every 35 days for a total of 3 courses. Maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell harvest) of initiation of the third course of induction, as follows: oral dexamethasone for 4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. Patients who achieved less than a 50% reduction in serum M protein or urinary Bence-Jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa. Combination therapy is continued until 2 years from entry; thereafter, interferon is administered alone for at least 3 years, toxicity permitting. Patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician. Patients are followed every 6 months for 2 years and yearly thereafter. PROJECTED ACCRUAL: A total of 100 patients (50 with prior melphalan/prednisone or iododoxorubicin treatment and 50 without) will be entered over 3 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.93 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 diagnosed primary systemic amyloidosis based on the following: Deposition of fibrillary protein with Congo red positive stain or characteristic electron microscopic appearance Monoclonal light chain protein (Bence-Jones protein) in serum or urine or immunohistochemical studies Evidence of tissue involvement other than carpal tunnel syndrome Diagnostic histologic material available for central pathology review Confirmation of tissue diagnosis at all sites of organ dysfunction encouraged No senile, secondary, localized, dialysis-related, or familial amyloidosis No known therapy-related myelodysplasia PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-4 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class IV status Other: No uncontrolled diabetes No active peptic ulcer disease No medical condition that precludes high-dose steroids No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer In situ cervical cancer Adequately treated stage I/II cancer in complete remission Not pregnant or nursing Effective contraception required of fertile patients Blood/body fluid analyses within 14 days prior to registration Imaging/exams for tumor measurement within 28 days prior to registration Other screening exams within 42 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy No prior interferon alfa Chemotherapy Prior melphalan allowed, but recovered from effects At least 4 weeks since cytotoxic therapy and recovered Endocrine therapy Prior prednisone allowed, but recovered from effects At least 4 weeks since prior glucocorticoids No prior dexamethasone No planned or concurrent dexamethasone or other therapy for primary systemic amyloidosis Radiotherapy Not specified Surgery Not specified
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 40 sites
Rebecca and John Moores UCSD Cancer Center
La Jolla, United StatesOuvrir Rebecca and John Moores UCSD Cancer Center dans Google MapsVeterans Affairs Medical Center - San Francisco
San Francisco, United StatesCCOP - Christiana Care Health Services
Wilmington, United StatesLombardi Cancer Center
Washington D.C., United States