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DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma

Primary Purpose

High-risk Soft Tissue Sarcoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Adenovirus-transfected DC + CIK
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High-risk Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intermediate or high grade sarcoma as determined by pathology review
  • Histopathologically confirmed diagnosis of intermediate or high grade sarcoma
  • Age≥18 years at time of consent
  • KPS(Karnofsky Performance Scale) ≥70
  • Patient's written informed consent
  • No steroid therapy within 4 weeks of first DC vaccination
  • Stable disease, complete response and partial response(WHO, RECIST)
  • Predicted survival≥3 months
  • Normal liver, kidney and marrow function: WBC≥3.5×109/L、PLT≥90×109/L and Hb≥90g/L; blood Cr≤1.5×UNL (upper normal limit) and blood BIL≤1.5×UNL; ALT、AST≤1.5×UNL and ALT/AST≤5.0×UNL

Exclusion Criteria:

  • Serious dysfunction of vital organs(heart, liver or kidney)
  • Received organ transplantation
  • Patients with other malignancies or brain metastases
  • History of autoimmune diseases
  • Pregnant and breast-feeding patient
  • Active or chronic infectious diseases
  • History of allergy or hypersensitivity to study product excipients
  • Currently participating in another clinical trial
  • Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
  • Unfit for participating in this clinical trial in investigators' opinions

Sites / Locations

  • Department of Hematopoietic Stem Cell Transplantation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adenovirus-transfected DC + CIK

Arm Description

Adenovirus-transfected autologous DCs + CIK cells

Outcomes

Primary Outcome Measures

Objective tumor response (CR+PR) as measured by RECIST criteria

Secondary Outcome Measures

Number of participants with adverse events

Full Information

First Posted
July 9, 2013
Last Updated
February 18, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01898663
Brief Title
DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma
Official Title
Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma: a Phase Ⅰ/Ⅱ Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with high-risk soft tissue sarcoma. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-risk Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adenovirus-transfected DC + CIK
Arm Type
Experimental
Arm Description
Adenovirus-transfected autologous DCs + CIK cells
Intervention Type
Biological
Intervention Name(s)
Adenovirus-transfected DC + CIK
Intervention Description
Adenovirus-transfected autologous DC vaccine plus CIK cells
Primary Outcome Measure Information:
Title
Objective tumor response (CR+PR) as measured by RECIST criteria
Time Frame
4 weeks after DC/CIK treatment
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
3 days within DC/CIK treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intermediate or high grade sarcoma as determined by pathology review Histopathologically confirmed diagnosis of intermediate or high grade sarcoma Age≥18 years at time of consent KPS(Karnofsky Performance Scale) ≥70 Patient's written informed consent No steroid therapy within 4 weeks of first DC vaccination Stable disease, complete response and partial response(WHO, RECIST) Predicted survival≥3 months Normal liver, kidney and marrow function: WBC≥3.5×109/L、PLT≥90×109/L and Hb≥90g/L; blood Cr≤1.5×UNL (upper normal limit) and blood BIL≤1.5×UNL; ALT、AST≤1.5×UNL and ALT/AST≤5.0×UNL Exclusion Criteria: Serious dysfunction of vital organs(heart, liver or kidney) Received organ transplantation Patients with other malignancies or brain metastases History of autoimmune diseases Pregnant and breast-feeding patient Active or chronic infectious diseases History of allergy or hypersensitivity to study product excipients Currently participating in another clinical trial Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks Unfit for participating in this clinical trial in investigators' opinions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Hu, M.D., Ph.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematopoietic Stem Cell Transplantation
City
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

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DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma

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