Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Phase 1

Completed

• Conditions: Glioma
• Interventions: Biological: gp96

• Registration Number: NCT02122822
• Lead Sponsor: Cure&Sure Biotech Co., LTD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-25
• Primary Completion: 2015-07
• Study Completion: 2017-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gp96 group	gp96	autologous gp96 vaccination + basal treatment

Primary Outcome Measures

Name	Time	Method
blood count	within 3 days after the 6th injection	blood count within 3 days after the 6th injection
blood chemistries	within 3 days after the 6th injection	blood chemistries test within 3 days after the 6th injection
electrocardiogram	within 3 days after the 6th injection	electrocardiogram test within 3 days after the 6th injection
progression-free survival rate of six month	six month after surgery	progression-free survival rate of six month

Secondary Outcome Measures

Name	Time	Method
tumor control rate	six month after surgery	tumor control rate at 6th month after surgery
progress free survive	up to 3 years
overall survive	up to 3 years
quality of life	up to 3 years
changes in antigen specific T cells	baseline and within 3 days before the 6th injection	tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

Trial Locations

Locations (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, China