Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study
aldesleukin
+ recombinant interferon alfa
+ fluorouracil
Maladies génito-urinaires+13
+ Adénocarcinome
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the toxic effects of interferon alfa, interleukin-2, gemcitabine, and fluorouracil in patients with metastatic or unresectable renal cell cancer. II. Evaluate the feasibility and possible therapeutic anticancer efficacy of this therapy in these patients. III. Determine the duration of response, survival, and improvement of quality of life in these patients. OUTLINE: Patients receive fluorouracil IV on days 1, 8, 15, and 22, followed by gemcitabine IV over 30 minutes on days 29, 36, 43, and 50. Interferon alfa is administered subcutaneously 3 times weekly beginning on day 1. Beginning on day 2, interleukin-2 is administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course. Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic effects and disease progression. Following chemobiotherapy, maintenance therapy is administered to patients with stable or responding disease. Patients receive subcutaneous interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or for a maximum of 1 year. A quality of life assessment is completed weekly. Patients are followed until death. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18-24 months.
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.30 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 70 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 metastatic or unresectable carcinoma of the kidney No CNS metastases PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 2,500/mm3 Platelet count at least 100,000/mm3 PT no greater than 1.3 times upper limit of normal (ULN) Hematocrit at least 28% Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 1.25 times ULN (unless due to tumor) Renal: Creatinine less than 2.0 mg/dL Calcium less than 12 mg/dL Proteinuria no greater than 2.0 by dipstick Cardiovascular: No active angina No uncontrolled congestive heart failure No uncontrolled arrhythmias No myocardial infarction within 6 months Pulmonary: No significant pulmonary disease (RA pO2 less than 60 or pCO2 greater than 50) Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection No daily emesis or inability to tolerate solid foods No prior or concurrent second malignancy within 2 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No sever diarrhea (greater than 4 watery stools per day) No active pelvic inflammatory disease No inflammatory bowel disease No uncontrolled seizure disorders No personal or family history of malignant hyperthermia No recent thromboembolism or any condition requiring concurrent anticoagulation PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy Chemotherapy: No prior gemcitabine No prior fluorouracil other than adjuvant fluorouracil received at least 1 year prior to study No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids not allowed (except for nausea or vomiting) Radiotherapy: At least 14 days since prior radiation to axial skeleton No concurrent radiotherapy (except to local lesions) Surgery: At least 14 days since prior exploration and biopsy At least 21 days since prior resection with anastomosis No major organ allograft Other: No concurrent barbiturates No concurrent oral anticoagulants No other concurrent investigational drugs or devices
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
Bergan Mercy Medical Center
Omaha, United States