Clinical trial · Interventional
Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
NCT00323115CI-TRIAL-00035213completedPhase 2Results postedClinicalTrials.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)
Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.
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 |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Dendritic Cell | Biological | — | UNRESOLVED |
| Dendritic Cell Vaccine | Biological | — | UNRESOLVED |
| Radiotherapy | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine
- interventionNames
- Biological: Autologous Dendritic Cell
- Drug: Temozolomide
- Procedure: Radiotherapy
- Biological: Dendritic Cell Vaccine
Primary outcomes (1)
- measure
- Tumor-specific Cytotoxic T-cell Response
- timeFrame
- Day 42
- description
- MRI \& pheresis post vaccine
Secondary outcomes (13)
- measure
- Number of Adverse Events: Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination
- timeFrame
- Until death or approximately 24 months after diagnosis
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical Center (DHMC) * Tumor specimen obtained at the time of surgery adequate for vaccination * 18 years of age or older * Karnofsky Performance Status 60% or greater * Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L * Platelets greater than or equal to 100 x 10 9th/L * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal to 5 times the upper limits of normal (ULN) * Total bilirubin less than or equal to 1.5 times ULN * Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine clearance greater than or equal to 60 mL/min * No known immunosuppression other than chemo-related * Negative HIV serologies * No evidence of acute or chronic hepatitis on standard hepatitis C and B screening tests * No chemotherapy within four weeks prior to leukapheresis * Radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at DHMC and patient is willing to follow-up per protocol * Off steroids for at least two weeks before leukapheresis * No second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical CIS, superficial bladder cancer or breast CIS * Negative serum or urine pregnancy test for women of childbearing potential * No serious uncontrolled medical disorder or active infection * All patients must give informed consent * No history of clinical evidence of active autoimmune disease Exclusion Criteria: * Invasive cancers in the past 5 years * Rheumatologic/autoimmune disease * Pregnancy or unwillingness to remain on acceptable form of birth control during study * Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection
References
Publications (1)
- RESULTFadul CE, Fisher JL, Hampton TH, Lallana EC, Li Z, Gui J, Szczepiorkowski ZM, Tosteson TD, Rhodes CH, Wishart HA, Lewis LD, Ernstoff MS. Immune response in patients with newly diagnosed glioblastoma multiforme treated with intranodal autologous tumor lysate-dendritic cell vaccination after radiation chemotherapy. J Immunother. 2011 May;34(4):382-9. doi: 10.1097/CJI.0b013e318215e300. PMID 21499132