Mix Vaccine for Metastatic Sarcoma Patients

Metastatic Sarcoma Clinical Trial

Official title:

Safety and Efficacy Study of Mix Vaccine in Sarcoma Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357315
• Other study ID #: sarcoma MV
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 30, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2018
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is the safety and efficacy of mix vaccine to small metastases of sarcoma.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Sarcoma
• Reaction - Mixed Vaccine
• Sarcoma

Intervention

Biological:
• Mix vaccine
Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle

Locations

Country	Name	City	State
China	Fuda cancer institute of Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Jinan University Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief degree of tumors	It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)	3 months
Secondary	Progress free survival(PFS)	The duration from the beginning of treatment to cancer recurrence or progression	1 year
Secondary	Overall survival(OS)	The duration from the beginning of treatment to patient death	3 years