Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

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.

Study Overview

• Status: Completed
• Conditions: Glioma
• Intervention / Treatment: Biological: gp96

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital Affiliated to Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gp96 group; autologous gp96 vaccination + basal treatment	Biological: gp96; vaccination of autologous gp96 derived from tumor tissue + basal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood count	blood count within 3 days before first vaccination	baseline
blood count	blood count within 3 days after the second injection	within 3 days after the second injection
blood count	blood count within 3 days after the 6th injection	within 3 days after the 6th injection
electrocardiogram	electrocardiogram test within 3 days before first vaccination	baseline
electrocardiogram	electrocardiogram test within 3 days after the second injection	within 3 days after the second injection
electrocardiogram	electrocardiogram test within 3 days after the 6th injection	within 3 days after the 6th injection
blood chemistries	blood chemistries test within 3 days before first vaccination	baseline
blood chemistries	blood chemistries test within 3 days after the second injection	within 3 days after the second injection
blood chemistries	blood chemistries test within 3 days after the 6th injection	within 3 days after the 6th injection
progression-free survival rate of six month	progression-free survival rate of six month	six month after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cure&Sure Biotech Co., LTD
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: zhixian Gao, Doctor, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Ji N, Zhang Y, Liu Y, Xie J, Wang Y, Hao S, Gao Z. Heat shock protein peptide complex-96 vaccination for newly diagnosed glioblastoma: a phase I, single-arm trial. JCI Insight. 2018 May 17;3(10):e99145. doi: 10.1172/jci.insight.99145. eCollection 2018 May 17.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: supratentoria glioma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: CS-TT-G-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No