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Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor
Phase 2 trial testing TTRNA-xALT in Medulloblastoma in 26 participants. Completed in 28 March 2025.
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 7 September 2010 |
| Primary completion | 28 March 2020 |
| Estimated completion | 28 March 2025 |
| Sites | 3 locations across United States |
University of Florida
Under 30, any sex, with Medulloblastoma or Neuroectodermal Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PFS is defined as time interval from date of first DC vaccine to date of progression (death is also treated as progression) or censoring, whichever happens first.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 215 | 110 – NA |
| Group B | 69 | 41 – 151 |
Time frame: There are two AE periods. The first begins at initiation of non-mobilized leukapheresis and ends 24 hrs after completion of the procedure. The second starts with initiation of consolidation or NMA chemotherapy and continues until 100 days after either the infusion of PBSCs or completion of chemotherapy for subjects not receiving PBSCs. AEs are not collected from the end of the leukapheresis period until the start of consolidation/NMA chemotherapy when subjects received salvage chemotherapy.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A | Group B |
|---|---|---|---|
| Hearing impaired | Ear and labyrinth disorders | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Pain | General disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiac Arrest | Cardiac disorders | — | — |
| Colitis, Infectious | Infections and infestations | — | — |
| Acidosis | Metabolism and nutrition disorders | — | — |
| Hydrocephalus | Nervous system disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Hyperbilirubinemia | Metabolism and nutrition disorders | — | — |
| Reaction | System | Group A | Group B |
|---|---|---|---|
| Lymphocyte count decreased | Investigations | — | — |
| neutrophil count decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Decreased platelet count | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fever | General disorders | — | — |
| hypophosphatemia | Metabolism and nutrition disorders | — | — |
| epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Ataxia | Nervous system disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Chest pain | Cardiac disorders | — | — |
| Confusion | Nervous system disorders | — | — |
| hypocalcemia | Metabolism and nutrition disorders | — | — |
| hypokalemia | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | — | — |
| Pain - access site | Injury, poisoning and procedural complications | — | — |
| Increased ALT | Investigations | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Enterocolitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| hypermagnesemia | Metabolism and nutrition disorders | — | — |
| hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Hearing impaired, Febrile Neutropenia, Hypotension, Pain, Hypoxia, Respiratory Arrest, Cardiac Arrest, Colitis, Infectious.
Data from ClinicalTrials.gov NCT01326104 adverse events section.
Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study investigators will use the experience they have gained from these studies to try to improve the outcome for children affected by a recurrent brain tumor. Approximately 35 patients with first recurrence of medulloblastoma (reMB)/supratentorial primitive neuroectodermal tumors (PNETs) will be treated with tumor-specific immune cells and dendritic cell vaccines to see what impact they have on the tumor.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing