Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

NCT02122822 — Phase 1, Completed, 20 participants, Cure&Sure Biotech Co., LTD

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RegistryNCT02122822
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none, treatment
Enrollment20 (Actual)
SponsorCure&Sure Biotech Co., LTD (Industry); collaborators: Beijing Tiantan Hospital
ConditionsGlioma
Interventionsgp96 (Biological)
Datesstart 2013-07-01, primary completion 2015-07-01, completion 2017-05-01, first posted 2014-04-25, last updated 2017-11-17
Locations1 site in China

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All trials for Glioma All trials of gp96

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
gp96 groupExperimentalBiological: gp96autologous gp96 vaccination + basal treatment
  • gp96 (Biological): vaccination of autologous gp96 derived from tumor tissue + basal treatment

+Outcome measures

Primary outcomes

  • blood count [baseline]: blood count within 3 days before first vaccination
  • blood count [within 3 days after the second injection]: blood count within 3 days after the second injection
  • blood count [within 3 days after the 6th injection]: blood count within 3 days after the 6th injection
  • blood chemistries [baseline]: blood chemistries test within 3 days before first vaccination
  • blood chemistries [within 3 days after the second injection]: blood chemistries test within 3 days after the second injection
  • blood chemistries [within 3 days after the 6th injection]: blood chemistries test within 3 days after the 6th injection
  • electrocardiogram [baseline]: electrocardiogram test within 3 days before first vaccination
  • electrocardiogram [within 3 days after the second injection]: electrocardiogram test within 3 days after the second 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

FacilityCityCountryStatus
Beijing Tiantan Hospital Affiliated to Capital Medical UniversityBeijingChina

+Publications

  • Results publication: 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

+Investigators