Mix Vaccine for Metastatic Sarcoma Patients

• Sponsor: Fuda Cancer Hospital, Guangzhou (Other)
• Overall Status: Completed
• CT.gov ID: NCT03357315
• Collaborator: Jinan University Guangzhou (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Sarcoma; Reaction - Mixed Vaccine	Biological: Mix vaccine	Phase 1/Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• 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
• Actual Study Start Date: Nov 30, 2017
• Actual Primary Completion Date: Nov 30, 2018
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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).

Outcome Measures

Primary Outcome Measures

1. Relief degree of tumors [3 months]

   It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

1. Progress free survival（PFS） [1 year]

   The duration from the beginning of treatment to cancer recurrence or progression

2. Overall survival（OS） [3 years]

   The duration from the beginning of treatment to patient death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fuda cancer institute of Fuda cancer hospital	Guangzhou	Guangdong	China	510665

Sponsors and Collaborators

• Fuda Cancer Hospital, Guangzhou
• Jinan University Guangzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fuda Cancer Hospital, Guangzhou
• ClinicalTrials.gov Identifier: NCT03357315
• Other Study ID Numbers: sarcoma MV
• First Posted: Nov 29, 2017
• Last Update Posted: Sep 12, 2019
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Sep 12, 2019