Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-induced Lymphopenia
- 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)
RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with radiation therapy and chemotherapy may kill more cancer cells. PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia caused by temozolomide.
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 |
|---|---|---|---|
| Malignant Neoplasms of Brain | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tetanus toxoid | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (first randomization)
- description
- Patients receive CMV-ALT IV over 45-90 minutes (course 1 only) and CMV pp65-LAMP mRNA-loaded DC (CMV-DC) vaccine intradermally and administered in equal portions to each inguinal region. Vaccination repeats every 1-3 weeks for up to 3 doses in the absence of unacceptable toxicity.
- interventionNames
- Biological: therapeutic autologous dendritic cells
- Biological: therapeutic autologous lymphocytes
- type
- EXPERIMENTAL
- label
- Arm II (first randomization)
- description
- Patients receive CMV-DC vaccine intradermally and administered in equal portions to each inguinal region. Vaccination repeats every 1-3 weeks for up to 3 doses in the absence of unacceptable toxicity.
- interventionNames
- Biological: therapeutic autologous dendritic cells
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years of age. * World Health Organization (WHO) Grade IV glioma with definitive resection prior to leukapheresis with residual radiographic contrast enhancement on most recent CT or MRI of \<1 cm in maximal diameter in any axial plane. * Karnofsky Performance Status (KPS ) of \> 80% and a Curran Group status of I-IV. Exclusion Criteria: * Radiographic or cytologic evidence of leptomeningeal or multicentric disease at the time of enrollment. * Prior conventional anti-tumor therapy other than steroids, RT, Avastin or TMZ. * Pregnant or need to breast feed during the study period (Negative Beta-Human Chorionic Gonadotrophin \[HCG\] test required). * Requirement for continuous corticosteroids above physiologic levels at time of first vaccination. * Active infection requiring treatment or an unexplained febrile (\> 101.5o F) illness. * Known immunosuppressive disease or human immunodeficiency virus infection. * Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease. * Allergic or unable to tolerate TMZ for reasons other than lymphopenia. * Patients with previous inguinal lymph node dissection.
References
Publications (2)
- RESULTMitchell DA, Batich KA, Gunn MD, Huang MN, Sanchez-Perez L, Nair SK, Congdon KL, Reap EA, Archer GE, Desjardins A, Friedman AH, Friedman HS, Herndon JE 2nd, Coan A, McLendon RE, Reardon DA, Vredenburgh JJ, Bigner DD, Sampson JH. Tetanus toxoid and CCL3 improve dendritic cell vaccines in mice and glioblastoma patients. Nature. 2015 Mar 19;519(7543):366-9. doi: 10.1038/nature14320. Epub 2015 Mar 11. PMID 25762141
- RESULTBatich KA, Reap EA, Archer GE, Sanchez-Perez L, Nair SK, Schmittling RJ, Norberg P, Xie W, Herndon JE 2nd, Healy P, McLendon RE, Friedman AH, Friedman HS, Bigner D, Vlahovic G, Mitchell DA, Sampson JH. Long-term Survival in Glioblastoma with Cytomegalovirus pp65-Targeted Vaccination. Clin Cancer Res. 2017 Apr 15;23(8):1898-1909. doi: 10.1158/1078-0432.CCR-16-2057. PMID 28411277