drugset / Trial / NCT03299309
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Phase 1
Active not recruiting
30 enrolled
Daniel Landi
Annias Immunotherapeutics, Inc. · collabPediatric Brain Tumor Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.
Timeline
- Start
- 2018-06-29
- Primary completion
- 2023-04-27
- Completion
- 2027-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEP-CMV | Vaccine | — | Other |
| Background | Temozolomide | Small molecule | 200 mg/m2 | — |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Other |
| Background | tetanus, diphtheria toxoid, adsorbed | Vaccine | — | Other |