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- Klinische proef 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
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Stanford, California, Verenigde Staten, 94305
- Stanford University Hospitals and Clinics
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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. |
Correlatieve studies
Gegeven PO
Andere namen:
SBRT ondergaan
Andere namen:
Undergo autologous PBMC infusion
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall survival (OS)
Tijdsspanne: 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.
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1 year
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Progression-free survival (PFS)
Tijdsspanne: 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.
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The duration from SBRT treatment to documented disease progression or death, assessed at 1 year
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Level of circulating tumor cells (CTCs)
Tijdsspanne: 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
Tijdsspanne: Up to 2 years
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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
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sandy Srinivas, Stanford University Hospitals and Clinics
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urologische neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Nier Ziekten
- Urologische ziekten
- Adenocarcinoom
- Neoplasmata, glandulair en epitheel
- Nierneoplasmata
- Carcinoom, niercel
- Carcinoom
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Cyclofosfamide
Andere studie-ID-nummers
- RENAL0027 (Andere identificatie: Stanford University Hospitals and Clinics)
- P30CA124435 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2013-01688 (Register-ID: CTRP (Clinical Trial Reporting Program))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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