Phase I Combined Modality Protocol for Malignant Mesothelioma: Cisplatin & rIFN-alpha-2b Followed by Surgical Resection (Debulking), and Post-Op Concurrent Chemoradiotherapy With Cisplatin, +/- rIFN-alpha-2b
recombinant interferon alfa
+ cisplatin
+ surgical procedure
Adénome+11
+ Maladies pulmonaires
+ Néoplasmes pulmonaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of neoadjuvant interferon alfa 2b (IFN-A2b) administered with cisplatin in patients with malignant pleural mesothelioma. II. Determine the MTD of IFN-A2b administered with radiation therapy and cisplatin after surgery in these patients. III. Determine the response rate and toxicity of induction therapy with IFN-A2b and cisplatin in these patients. IV. Determine the toxicity of concurrent radiation therapy, cisplatin, and IFN-A2b after surgery in these patients. V. Determine the local control rate, freedom from progression, median survival, and long term survival of these patients after combined modality therapy. OUTLINE: This is a dose escalation study. Patients receive induction therapy consisting of cisplatin IV weekly and interferon alfa 2b (IFN-A2b) subcutaneously three times a week for 6 weeks. Patients who experience at least 25% tumor shrinkage receive another 4 weeks of therapy. Patients then undergo debulking surgery to remove all gross tumor, if possible. If this resection is performed, then patients begin radiation therapy 2-6 weeks after surgery. Patients with unresectable tumors begin radiation therapy 2-4 weeks after the last course of induction chemotherapy. Patients undergo radiation therapy 5 days a week for 6 weeks. Concurrently, patients receive cisplatin IV weekly and IFN-A2b subcutaneously three times a week. Cohorts of 4 patients each receive escalated doses of IFN-A2b during induction chemotherapy. Once the maximum tolerated dose (MTD) of IFN-A2b is established, one dose level below this dose is used for the beginning doses of IFN-A2b during adjuvant chemotherapy. If no unacceptable toxic effects occur, then the dose of IFN-A2b is escalated to the induction MTD. Patients are followed at 3-6 weeks after completing radiochemotherapy, then every 3 months thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2-3 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.6 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 ipsilateral malignant pleural mesothelioma No contralateral thoracic or intra-abdominal involvement No distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 No symptomatic anemia requiring transfusion Hepatic: Bilirubin less than 2.0 mg/dL No autoimmune hepatitis No history of decompensated liver disease; e.g. esophageal varices Ascites Albumin at least 2.5 mg/dL Increasing prothrombin time of at least 2.0 Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic or debilitating cardiovascular disease, No concurrent thrombophlebitic or embolic disorders Pulmonary: No symptomatic or debilitating pulmonary disease, Pretreatment diffusion capacity greater than 30% of predicted normal Projected post-treatment FEV1 at least 1.0 L Other: No prior malignancy within 3 years, except nonmelanomatous skin cancer Carcinoma in situ of the cervix Ductal carcinoma in situ of the breast Not pregnant Fertile patients must use effective contraception No history of hypersensitivity to interferon or any component of the injection No uncontrolled diabetes (blood sugars consistently at least 300 mg/dL) No insulin dependent diabetes mellitus with history of ketoacidosis within 1 year No psychosis No uncontrolled thyroid abnormalities No active infection requiring intravenous antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior debulking surgery No prior chest tube drainage with sclerosis if tumor resectable Prior thoracentesis allowed
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 3 sites
Fox Chase Cancer Center
Philadelphia, United StatesVirginia Oncology Associates
Newport News, United States