Overview

This trial is active, not recruiting.

Condition glioma
Treatment gp96
Phase phase 1
Sponsor Cure&Sure Biotech Co., LTD
Collaborator Beijing Tiantan Hospital
Start date July 2013
End date July 2015
Trial size 20 participants
Trial identifier NCT02122822, CS-TT-G-01

Summary

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of glioblastoma and to see how well it works in treating patients with newly diagnosed supratentoria glioma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
autologous gp96 vaccination + basal treatment
gp96
vaccination of autologous gp96 derived from tumor tissue + basal treatment

Primary Outcomes

Measure
blood count
time frame: baseline
blood count
time frame: within 3 days after the second injection
blood count
time frame: within 3 days after the 6th injection
blood chemistries
time frame: baseline
blood chemistries
time frame: within 3 days after the second injection
blood chemistries
time frame: within 3 days after the 6th injection
electrocardiogram
time frame: baseline
electrocardiogram
time frame: within 3 days after the second injection
electrocardiogram
time frame: within 3 days after the 6th injection
progression-free survival rate of six month
time frame: six month after surgery

Secondary Outcomes

Measure
tumor control rate
time frame: six month after surgery
progress free survive
time frame: up to 3 years
overall survive
time frame: up to 3 years
quality of life
time frame: up to 3 years
changes in antigen specific T cells
time frame: baseline and within 3 days before the 6th injection

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Able to read and understand the informed consent document; must sign the informed consent. 2. Aged 18 to 75 years old , sex is not limited 3. Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection 4. Availability of at least 1 g tumor sample. 5. Karnofsky functional status rating > or equal to 70. 6. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs) 7. Agree to Surgical indications of Heart & lung and without the coagulation system disease 8. Negative pregnancy test for female patients of childbearing potential 9. Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration Exclusion Criteria: 1. Inability to comply with study-related procedures 2. patient not suitable for Neurosurgery. 3. Unavailability of at least 6 doses of vaccine 4. Progression prior to vaccination as determined by the Principal Investigator 5. Patient with allergic constitution 6. Unstable or severe intercurrent medical conditions 7. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. 8. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. 9. any other clinical trials within 30 days pre-vaccination. 10. Female patients who are pregnant or breastfeeding

Additional Information

Official title Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Principal investigator Zhixian Gao, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Cure&Sure Biotech Co., LTD.