Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

NCT02122822 | Completed Phase 1 DMC

• 1 other identifier: CS-TT-G-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

supratentoria glioma

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• progression-free survival rate of six month

  progression-free survival rate of six month

  six month after surgery

Secondary Outcomes (5)

• tumor control rate

  six 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

Study Arms (1)

gp96 group

EXPERIMENTAL

autologous gp96 vaccination + basal treatment

Biological: gp96

Interventions

gp96 BIOLOGICAL

vaccination of autologous gp96 derived from tumor tissue + basal treatment

gp96 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and understand the informed consent document; must sign the informed consent.
• Aged 18 to 75 years old , sex is not limited
• Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection
• Availability of at least 1 g tumor sample.
• Karnofsky functional status rating \> or equal to 70.
• 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)
• Agree to Surgical indications of Heart \& lung and without the coagulation system disease
• Negative pregnancy test for female patients of childbearing potential
• Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration

You may not qualify if:

• Inability to comply with study-related procedures
• patient not suitable for Neurosurgery.
• Unavailability of at least 6 doses of vaccine
• Progression prior to vaccination as determined by the Principal Investigator
• Patient with allergic constitution
• Unstable or severe intercurrent medical conditions
• Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
• patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
• any other clinical trials within 30 days pre-vaccination.
• Female patients who are pregnant or breastfeeding

Sponsors & Collaborators

• Cure&Sure Biotech Co., LTD: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 29769450 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

glucose-regulated proteins

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Zhixian Gao, Doctor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 25, 2014
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: May 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

CN (1)