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GliomaPhase 1NCT02122822

Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

A Phase 1 study testing gp96 in people with Glioma, run by Cure&Sure Biotech Co., LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glioma
What is being tested?
gp96
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Jul 2013to May 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing

Other trials in China

About this study

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
Being tested
gp96
Keywords
supratentoria glioma
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gp96Biological

    vaccination of autologous gp96 derived from tumor tissue + basal treatment

Study groups in NCT02122822
Study groupRoleWhat they receive
gp96 groupExperimentalautologous gp96 vaccination + basal treatment
Receives: Biological: gp96

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood count

    blood count within 3 days before first vaccination

    Measured: baseline

  2. blood count

    blood count within 3 days after the second injection

    Measured: within 3 days after the second injection

  3. blood count

    blood count within 3 days after the 6th injection

    Measured: within 3 days after the 6th injection

  4. blood chemistries

    blood chemistries test within 3 days before first vaccination

    Measured: baseline

  5. blood chemistries

    blood chemistries test within 3 days after the second injection

    Measured: within 3 days after the second injection

  6. blood chemistries

    blood chemistries test within 3 days after the 6th injection

    Measured: within 3 days after the 6th injection

  7. electrocardiogram

    electrocardiogram test within 3 days before first vaccination

    Measured: baseline

  8. electrocardiogram

    electrocardiogram test within 3 days after the second injection

    Measured: within 3 days after the second injection

  9. electrocardiogram

    electrocardiogram test within 3 days after the 6th injection

    Measured: within 3 days after the 6th injection

  10. progression-free survival rate of six month

    progression-free survival rate of six month

    Measured: six month after surgery

Secondary outcomes (5)

  1. tumor control rate

    tumor control rate at 6th month after surgery

    Measured: six month after surgery

  2. progress free survive

    Measured: up to 3 years

  3. overall survive

    Measured: up to 3 years

  4. quality of life

    Measured: up to 3 years

  5. 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.

    Measured: baseline and within 3 days before the 6th injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2015
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02122822
Sponsor's protocol ID
CS-TT-G-01
Status last verified
Nov 2017
First submitted
23 Apr 2014
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29769450

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gp96 in people with Glioma, run by Cure&Sure Biotech Co., LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood count (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02122822, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

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