- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01943188
Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer
Pilot Study of Local Tumor Irradiation With Autologous T-Cell Infusion for Metastatic Renal Cell Carcinoma
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
I. Conduct a safety and feasibility study of stereotactic radiotherapy with autologous T-cell infusion for patients with metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
I. Determine the progression free survival at one year. II. Determine the overall survival at one year.
OUTLINE:
STEREOTACTIC BODY RADIATION THERAPY (SBRT): Patients undergo standard of care SBRT over 1-2 weeks according to tumor volume and location.
LYMPHODEPLETION: Beginning 3 weeks later, patients receive cyclophosphamide orally (PO) twice daily (BID) for 3 days.
REINFUSION OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC): Within 3-14 days of completing lymphodepletion with cyclophosphamide, patients undergo autologous PBMC infusion.
After completion of study treatment, patients are followed up at 1 week, 4 weeks, and monthly thereafter.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Stanford, California, États-Unis, 94305
- Stanford University Hospitals and Clinics
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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
Inclusion Criteria:
- Histologically confirmed carcinoma of the kidney (clear-cell predominance)
- Have had at least 2 prior systemic treatments for renal cell carcinoma (RCC)
- Have at least 1 extracranial metastasis that is amenable to radiation and at least 1 other site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST)
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Absolute neutrophil count (ANC) >= 0.75 x 10^9/L
- Absolute lymphocyte count (ALC) >= 0.5 X 10^9/L
- Hemoglobin >= 8 g/dL
- Platelets >= 50 X 10^9/L
- Total bilirubin =< 3 X upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 X ULN
- Serum creatinine =< 2.1 X ULN (or creatinine clearance of > 50 cc/min)
Exclusion Criteria:
History of other malignancies within 5 years prior to enrollment except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
- Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to enrollment may be discussed with the lead primary investigator
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for more than 1 week within 6 months prior enrollment
- Presence of uncontrolled infection
- Evidence of active bleeding or bleeding diathesis; any medical condition requiring systemic anticoagulation (including anti-platelet agents)
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to procedures
- Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Treatment (SBRT, autologous PBMC infusion)
SBRT: Patients undergo standard of care SBRT over 1-2 weeks according to tumor volume and location. LYMPHODEPLETION: Beginning 3 weeks later, patients receive cyclophosphamide PO BID for 3 days. REINFUSION OF PBMC: Within 3-14 days of completing lymphodepletion with cyclophosphamide , patients undergo autologous PBMC infusion. |
Études corrélatives
Bon de commande donné
Autres noms:
Subir SBRT
Autres noms:
Undergo autologous PBMC infusion
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Frequency of treatment-related grade 3-5 toxicities, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Délai: Within 30 days after infusion of PBMCs
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Adverse events will be tabulated by type and grade at each follow-up interval.
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Within 30 days after infusion of PBMCs
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall survival (OS)
Délai: 1 year
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The level of OS will be tabulated at each follow-up interval, and will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals.
|
1 year
|
Progression-free survival (PFS)
Délai: The duration from SBRT treatment to documented disease progression or death, assessed at 1 year
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The level of PFS will be tabulated at each follow-up interval.
The percentage of individuals free from disease progression will be computed with exact 95% confidence intervals.
PFS will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals.
|
The duration from SBRT treatment to documented disease progression or death, assessed at 1 year
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Level of circulating tumor cells (CTCs)
Délai: Up to 2 years
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The correlations of CTCs and changes in signaling as measured by nano-immunoassay (NIA) to clinical response will be assessed.
NIA measurements for 20 protein isoforms will be analyzed.
Measurements will be analyzed as continuous variables for each sample.
The distribution of each isoform will be summarized with medians and interquartile ranges.
Quantile plot and box-Cox models will be used to determine whether to transform the data prior to analysis.
A protein isoform signature predictive of clinical response will be constructed using the Lasso R glmnet package.
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Up to 2 years
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Changes in signaling as measured by NIA
Délai: Up to 2 years
|
The correlations of CTCs and changes in signaling as measured by NIA to clinical response will be assessed.
NIA measurements for 20 protein isoforms will be analyzed.
Measurements will be analyzed as continuous variables for each sample.
The distribution of each isoform will be summarized with medians and interquartile ranges.
Quantile plot and box-Cox models will be used to determine whether to transform the data prior to analysis.
A protein isoform signature predictive of clinical response will be constructed using the Lasso R glmnet package.
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Up to 2 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sandy Srinivas, Stanford University Hospitals and Clinics
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urologiques
- Tumeurs urogénitales
- Tumeurs par site
- Maladies rénales
- Maladies urologiques
- Adénocarcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs rénales
- Carcinome à cellules rénales
- Carcinome
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents antirhumatismaux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Cyclophosphamide
Autres numéros d'identification d'étude
- RENAL0027 (Autre identifiant: Stanford University Hospitals and Clinics)
- P30CA124435 (Subvention/contrat des NIH des États-Unis)
- NCI-2013-01688 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
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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