Clinical trial NCT02122822: Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Official title: Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioma
Keywords: supratentoria glioma
Lead sponsor: Cure&Sure Biotech Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: blood count
timeFrame: baseline
measure: blood count
timeFrame: within 3 days after the second injection
measure: blood count
timeFrame: within 3 days after the 6th injection
measure: blood chemistries
timeFrame: baseline
measure: blood chemistries
timeFrame: within 3 days after the second injection
measure: blood chemistries
timeFrame: within 3 days after the 6th injection
measure: electrocardiogram
timeFrame: baseline
measure: electrocardiogram
timeFrame: within 3 days after the second injection
measure: electrocardiogram
timeFrame: within 3 days after the 6th injection
measure: progression-free survival rate of six month
timeFrame: six month after surgery
Secondary outcomes:
measure: tumor control rate
timeFrame: six month after surgery
measure: progress free survive
timeFrame: up to 3 years
measure: overall survive
timeFrame: up to 3 years
measure: quality of life
timeFrame: up to 3 years
measure: changes in antigen specific T cells
timeFrame: baseline and within 3 days before the 6th injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zhixian Gao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.