Clinical trial · Interventional
Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
Newly diagnosed glioblastoma (GBM) patients with complete or partial surgical resection who were CMV seropositive patients were eligible to enroll on this trial. Patients were enrolled following standard of care chemoradiation and prior to initiation of post-radiation cycles of temozolomide (TMZ) provided they met all eligibility criteria. All eligible patients received a tetanus-diphtheria (Td) vaccination. Patients enrolled on study were randomized to receive either standard TMZ or dose-intensified TMZ (excluding the safety cohort who only received standard TMZ). All patients received a pre-conditioning injection of tetanus on day 22 of the first post-radiation cycle of TMZ. The following day, patients received the first of 3 intradermal (i.d.) injections of the study drug cytomegalovirus peptide (PEP-CMV), which contained either a combination of Component A and Component B or Component A only depending upon when they enrolled on study. Vaccines #2 and #3 will be given at 2 week intervals. Patients who were O\[6\]-methylguanine-DNA methyltransferase (MGMT) unmethylated received one adjuvant cycle of the TMZ regimen according to their assigned TMZ arm. Patients who were MGMT methylated or whose methylation status was inconclusive continue with up to 12 cycles of TMZ. After the completion of a patient's last TMZ cycle, vaccines continued every 4-6 weeks for a maximum number of 20 vaccines (unless tumor progression occurred). The study ended prematurely due to lack of funds. The preliminary results suggest that the vaccine may be capable of generating an immune response.
Conditions
Conditions (2)
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 | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 21-day TMZ | Drug | — | UNRESOLVED |
| 5-day TMZ | Drug | — | UNRESOLVED |
| PEP-CMV: Component A | Biological | — | UNRESOLVED |
| PEP-CMV: Component B | Biological | — | UNRESOLVED |
| Tetanus-Diphtheria booster | Drug | — | UNRESOLVED |
| Tetanus Pre-Conditioning | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 5-day TMZ: Components A and B
- description
- All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of standard TMZ (150-200 mg/m\^2/day on days 1-5 of each 28 day cycle) with PEP-CMV vaccination on Day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
- interventionNames
- Drug: 5-day TMZ
- Biological: PEP-CMV: Component A
- Drug: Tetanus-Diphtheria booster
- Drug: Tetanus Pre-Conditioning
- Biological: PEP-CMV: Component B
- type
- EXPERIMENTAL
- label
- 21-day TMZ: Components A and B
- description
- All patients receive Tetanus-Diphtheria booster vaccine at time of enrollment. Cycles of dose-intensified TMZ (75-100 mg/m\^2/day on days 1-21 of each 28 day cycle) with PEP-CMV vaccination on day 23 (-1 day, + 2 days) of each TMZ cycle and tetanus pre-conditioning the day before the first vaccine.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histopathologically proven newly-diagnosed primary glioblastoma with complete or partial surgical resection. Biopsy not acceptable. 3. Patients must be cytomegalovirus (CMV) seropositive. 4. The tumor must be supratentorial. 5. Karnofsky performance status of ≥ 70. 6. Stable or decreasing steroid dose (≤ 4 mg/day) at time of post-radiation treatment (XRT) adjuvant TMZ initiation. If patients are decreasing steroid use, once they are at 2 mg/day, they may be supplemented with physiologic replacement hydrocortisone therapy (20-30 mg/day in divided doses), at the discretion of the treating oncologist. 7. Hematology: absolute neutrophil count (ANC) ≥ 1500 cells/µL, Platelet count ≥ 100,000 cells/µL, Hemoglobin ≥ 9.0 g/dl 8. Chemistry: ALT/AST ≤ 3.0 times the upper limit of normal (ULN), Total bilirubin ≤ 1.5 mg x ULN (Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.) Exclusion Criteria: 1. Radiographic or cytologic evidence of leptomeningeal or multifocal disease at any time prior to study entry. 2. Prior conventional antitumor therapy, other than steroids, RT or TMZ therapy given for glioblastoma. 3. Pregnant or need to breast feed during the study period. 4. Not adhering to pregnancy prevention recommendations. 5. Active infection requiring intravenous antibiotics or an unexplained febrile (\> 101.5 F) illness. 6. Immunosuppressive disease or human immunodeficiency virus infection. 7. Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease. 8. Allergic or unable to tolerate TMZ for any reason. Any patient that successfully completed at least 5 weeks of Temodar during standard of care XRT/TMZ and whose blood counts meet the eligibility requirements (inclusion #7) within 4 weeks post XRT/TMZ is eligible. 9. Patients with previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies. 10. Prior allogeneic solid organ transplant. 11. Currently receiving or ever received immunosuppressive therapy for an autoimmune disorder or an organ transplant.
References
Publications (0)
Data not yet available