- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00045370
Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Intravenous CCI-779 Given in Combination With Escalating Doses of Interferon-Alpha to Patients With Advanced Renal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer.
- Determine the safety and tolerability of this regimen in these patients.
- Determine, preliminarily, any antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive interferon alfa (IFN-A) subcutaneously 3 times a week. Beginning on week 2, patients also receive CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at that dose level.
Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced or metastatic renal cell cancer
- Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease
- Measurable or evaluable disease
No concurrent CNS metastases
- Prior CNS metastases allowed if no residual disease by MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal
- Creatinine less than 2 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No unstable angina
- No myocardial infarction within the past 6 months
Other
- Cholesterol no greater than 350 mg/dL
- Triglycerides no greater than 400 mg/dL
- HIV negative
- Not immunocompromised
- No active autoimmune disorder
- No active infection requiring antibiotic therapy
- No other serious concurrent illness
- No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs
- No other major illness that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 3 weeks since prior immunotherapy
- No prior interferon alfa
- No other concurrent immunotherapy
- No prophylactic growth factors
- Concurrent epoetin alfa allowed
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy
- No prior CCI-779
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed)
- Concurrent inhaled or replacement steroids allowed
Radiotherapy
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 3 weeks since prior surgery
Other
- See Disease Characteristics
- At least 3 weeks since prior immunosuppressive agents
- At least 4 weeks since prior investigational agents
- No other concurrent investigational agents
- No concurrent immunosuppressive therapy
- No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide
- No concurrent maintenance therapy for life-threatening ventricular arrhythmia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urologiques
- Tumeurs urogénitales
- Tumeurs par site
- Maladies rénales
- Maladies urologiques
- Adénocarcinome
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs rénales
- Carcinome à cellules rénales
- Effets physiologiques des médicaments
- Agents anti-infectieux
- Agents antiviraux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antibactériens
- Antibiotiques, Antinéoplasiques
- Agents antifongiques
- Interférons
- Interféron-alpha
- Sirolimus
Autres numéros d'identification d'étude
- 02-023
- CDR0000256468 (Identificateur de registre: PDQ (Physician Data Query))
- NCI-G02-2104
- W-AR-3066K1-124-US
- WYETH-C-C0125-32
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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