NCT02787915

Brief Summary

This trial is to evaluate the safety and effectiveness of autologous type-1 polarized dendritic cell vaccines (patients' autologous DC1s loaded with multiple antigens CTL epitope peptide complexes), after radical resection for patients with stage III-IV renal cell carcinoma. Autologous cytotoxic of T lymphocytes (CTL) induced by type-1 polarized dendritic cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

May 26, 2016

Last Update Submit

May 31, 2016

Conditions

Renal Cell Carcinoma

Keywords

dendritic cellscytotoxic T lymphocyteDC vaccine

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Our primary objective is to evaluate whether our cellular therapy regimen is safe.

    24 weeks

Secondary Outcomes (1)

  • G250 mRNA figures

    24 weeks

Other Outcomes (2)

  • T cell subsets figures

    12 weeks

  • Serum cytokine secretion figures

    12 weeks

Study Arms (1)

dendritic cell vaccine

EXPERIMENTAL

DC1-CTL cellular therapy

Biological: DC1-CTL

Interventions

DC1-CTLBIOLOGICAL

Autologous cytotoxic of T lymphocytes (CTL) were induced by type-1 polarized dendritic cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .

dendritic cell vaccine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed stage III-IV renal malignancies; The patient underwent radical operation of RCC within 8 weeks before enrollment; Must have normal marrow hematopoiesis function as defined below: Hemoglobin≥90g/L, WBC\>4000/mm3, Absolute Neutrophil Count (ANC)≥1500/µL, Platelet≥ 100,000/µL, Must have normal important organ function as defined below: Total bilirubin≤1.5 x institutional upper limit of normal(ULN), AST(SGOT) and ALT(SGPT)≤2.5x ULN , ALP≤1.5x ULN; BUN and Creatinine \<1.5x ULN, Creatinine clearance ≥80mL/min.
  • life expectancy≥3 months; No other serious heart, liver and kidney organ dysfunction; Quality of life score (Karnofsky performance score) ≥60; Patients must be able to understand and be willing to sign a written informed consent document.

You may not qualify if:

  • Prior allergic reaction or hypersensitivity to cytokines (eg.IL-2); Patients with systemic or local infection requiring anti-infectious treatment; Patients currently treated with systemic immunosuppressive agents, including steroids, Patients with active autoimmune disease or history of transplantation requiring steroid treatment; Tested positive for HIV; Pregnant or lactating women Patients with important organ dysfunction; Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Junnian Zheng, MD

    Xuzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junnian Zheng, MD

CONTACT

86-0516-83372010jnzheng@xzmc.edu.cn

Huizhong Li, MM

CONTACT

86-0516-85582635lhz@xzmc.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

June 2, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share