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Completed

NCT Number: NCT02122822

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

gp96

Biological

vaccination of autologous gp96 derived from tumor tissue + basal treatment

Primary outcomes

  1. blood count

    Time frame: baseline

    blood count within 3 days before first vaccination

  2. blood count

    Time frame: within 3 days after the second injection

    blood count within 3 days after the second injection

  3. blood count

    Time frame: within 3 days after the 6th injection

    blood count within 3 days after the 6th injection

  4. blood chemistries

    Time frame: baseline

    blood chemistries test within 3 days before first vaccination

  5. blood chemistries

    Time frame: within 3 days after the second injection

    blood chemistries test within 3 days after the second injection

  6. blood chemistries

    Time frame: within 3 days after the 6th injection

    blood chemistries test within 3 days after the 6th injection

  7. electrocardiogram

    Time frame: baseline

    electrocardiogram test within 3 days before first vaccination

  8. electrocardiogram

    Time frame: within 3 days after the second injection

    electrocardiogram test within 3 days after the second injection

  9. electrocardiogram

    Time frame: within 3 days after the 6th injection

    electrocardiogram test within 3 days after the 6th injection

  10. progression-free survival rate of six month

    Time frame: six month after surgery

    progression-free survival rate of six month

Secondary outcomes

  1. tumor control rate

    Time frame: six month after surgery

    tumor control rate at 6th month after surgery

  2. progress free survive

    Time frame: up to 3 years

  3. overall survive

    Time frame: up to 3 years

  4. quality of life

    Time frame: up to 3 years

  5. changes in antigen specific T cells

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cure&Sure Biotech Co., LTD

Industry

Collaborators

  • Beijing Tiantan Hospital

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Apr 25, 2014
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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