TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
aldesleukin
+ conventional surgery
Maladies génito-urinaires+13
+ Adénocarcinome
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1995
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2. Assess the toxicity associated with this treatment. OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited. Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 14 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.14 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 confirmed renal cell carcinoma (RCC) that is metastatic or recurrent No central nervous system or major nerve involvement No more than 25% estimated hepatic replacement by tumor on CT or MRI Measurable disease required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: Greater than 3 months Hematopoietic: Platelet count at least 80,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 3 times normal Renal: Creatinine normal Cardiovascular: Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG) Pulmonary: FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray) Other: No sites of ongoing bleeding No HIV antibody or AIDS No hepatitis B antigen No systemic infection No requirement for steroids No psychiatric disease that precludes informed consent or safe administration of immunotherapy No second malignancy except: Basal cell carcinoma In situ cervical cancer Other cancer provided all evaluable lesions are documented RCC No pregnant or nursing women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 therapy Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 28 days since therapy for RCC
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