Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Cure&Sure Biotech

Status and phase: Completed; Phase 1

Conditions: Glioma

Treatments: Biological: gp96

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02122822

CS-TT-G-01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

gp96 group

Experimental group

Description:

autologous gp96 vaccination + basal treatment

Treatment:

Biological: gp96