We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 45 for:    sarcoma vaccine

Mix Vaccine for Metastatic Sarcoma Patients

This study is currently recruiting participants.
Verified November 2017 by Fuda Cancer Hospital, Guangzhou
Sponsor:
ClinicalTrials.gov Identifier:
NCT03357315
First Posted: November 29, 2017
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Biomedical Translational Research Institute of Jinan University
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou
  Purpose
The aim of this study is the safety and efficacy of mix vaccine to small metastases of sarcoma.

Condition Intervention Phase
Metastatic Sarcoma Reaction - Mixed Vaccine Biological: Mix vaccine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Mix Vaccine in Sarcoma Patient

Resource links provided by NLM:


Further study details as provided by Fuda Cancer Hospital, Guangzhou:

Primary Outcome Measures:
  • Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)


Secondary Outcome Measures:
  • Progress free survival(PFS) [ Time Frame: 1 year ]
    The duration from the beginning of treatment to cancer recurrence or progression

  • Overall survival(OS) [ Time Frame: 3 years ]
    The duration from the beginning of treatment to patient death


Estimated Enrollment: 30
Anticipated Study Start Date: November 30, 2017
Estimated Study Completion Date: November 30, 2020
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mix vaccine
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).
Biological: Mix vaccine
Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Other Name: Active immunotherapy for cancer
No Intervention: Control
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).

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357315


Locations
China, Guangdong
Fuda cancer institute of Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Jibing Chen, MD, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Biomedical Translational Research Institute of Jinan University
  More Information

Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03357315     History of Changes
Other Study ID Numbers: sarcoma MV
First Submitted: November 23, 2017
First Posted: November 29, 2017
Last Update Posted: November 30, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs