Back to resultsMix Vaccine for Metastatic Sarcoma Patients
Primary Purpose
Metastatic Sarcoma, Reaction - Mixed Vaccine
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mix vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Sarcoma
Eligibility Criteria
Inclusion Criteria:
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- Body tumor 1-6, the maximum tumor length < 2 cm
- KPS ≥ 70, lifespan > 6 months
- Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion Criteria:
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Sites / Locations
- Fuda cancer institute of Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mix vaccine
Control
Arm Description
In this group, the patients will receive mix vaccine. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
In this group, the patients will receive no special treatment and as a control group. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Outcomes
Primary Outcome Measures
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Secondary Outcome Measures
Progress free survival（PFS）
The duration from the beginning of treatment to cancer recurrence or progression
Overall survival（OS）
The duration from the beginning of treatment to patient death
Full Information
NCT ID
NCT03357315
First Posted
November 23, 2017
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT03357315
Brief Title
Mix Vaccine for Metastatic Sarcoma Patients
Official Title
Safety and Efficacy Study of Mix Vaccine in Sarcoma Patient
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is the safety and efficacy of mix vaccine to small metastases of sarcoma.
Detailed Description
By enrolling patients with small metastases of sarcoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Sarcoma, Reaction - Mixed Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mix vaccine
Arm Type
Experimental
Arm Description
In this group, the patients will receive mix vaccine. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group, the patients will receive no special treatment and as a control group. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention Type
Biological
Intervention Name(s)
Mix vaccine
Other Intervention Name(s)
Active immunotherapy for cancer
Intervention Description
Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Primary Outcome Measure Information:
Title
Relief degree of tumors
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progress free survival（PFS）
Description
The duration from the beginning of treatment to cancer recurrence or progression
Time Frame
1 year
Title
Overall survival（OS）
Description
The duration from the beginning of treatment to patient death
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
Body tumor 1-6, the maximum tumor length < 2 cm
KPS ≥ 70, lifespan > 6 months
Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion Criteria:
Patients with cardiac pacemaker
Patients with brain metastasis
Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Facility Information:
Facility Name
Fuda cancer institute of Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China
12. IPD Sharing Statement
Learn more about this trial
Mix Vaccine for Metastatic Sarcoma Patients
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