Clinical trial · Interventional
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
NCT03650257CI-TRIAL-00043982unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp96 | Biological | — | UNRESOLVED |
| radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gp96 group
- description
- Patients receive standard treatment with radiation and temozolomide after surgery. Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy. ( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. ) The first adjunctive temozolomide startes on the day of the fifth gp96 injection. (150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)
- interventionNames
- Biological: gp96
- Drug: Temozolomide
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 4 g tumor sample; 5. Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and radiotherapy). 6. Karnofsky functional status rating \> or equal to 70. 7. 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) 8. Agree to Surgical indications of Heart \& lung and without the coagulation system disease 9. Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no other cancer treatment is received. Exclusion Criteria: 1. Inability to comply with study-related procedures 2. Unavailability of at least 6 doses of vaccine 3. Severe allergies 4. Unstable or severe intercurrent medical conditions 5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection. 6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids. 7. any other clinical trials within 30 days pre-vaccination. 8. Female patients who are pregnant or breastfeeding 9. Carmustine extended release implant surgery within 6 months 10. Steroidal drugs are currently being used systemically.
References
Publications (0)
Data not yet available
No reference posted for this study.