Clinical trial · Interventional
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients
- 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 made from a person's white blood cells and tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine
- interventionNames
- Biological: therapeutic autologous dendritic cells
Primary outcomes (1)
- measure
- Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- survival
- timeFrame
- 1 year
- description
- survival with this vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed\* WHO grade III or IV malignant glioma of 1 of the following subtypes: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme NOTE: \*Must be confirmed after surgery * Newly diagnosed OR recurrent disease * Bidimensionally measurable disease by contrast-enhancing pre-operative MRI * Surgically accessible tumor for which surgical resection is indicated at the time of initial pre-operative evaluation * Must have undergone standard surgery\* AND either radiotherapy\* or chemoradiotherapy\* * Objective evidence of disease by contrast-enhanced brain MRI after completion of standard therapy NOTE: \*Completed after study entry but before assignment to study treatment cohorts * Age 1 to 18 * Performance status Karnofsky 60-100% * Hematopoietic * Hemoglobin ≥ 10 g/dL * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hepatic * SGPT and SGOT ≤ 2 times normal * Alkaline phosphatase ≤ 2 times normal * Bilirubin ≤ 1.5 mg/dL * Hepatitis B and C negative * Renal * BUN ≤ 1.5 times normal OR * Creatinine ≤ 1.5 times normal * Immunologic * HIV negative * Syphilis negative * At least 2 weeks since prior radiotherapy and recovered * Negative pregnancy test * Fertile patients must use effective contraception * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No chemotherapy during and for 4 weeks\* after the final dose of study vaccine * No corticosteroids for at least 10 days before leukapheresis * No concurrent corticosteroids * More than 72 hours since prior systemic antibiotics * No antihistamines for 5 days before and for 5 days after administration of study vaccine Exclusion Criteria: * history of immunodeficiency or autoimmune disease that may be exacerbated by immunotherapy, including any of the following: * Rheumatoid arthritis * Systemic lupus erythematosus * Vasculitis * Polymyositis * Dermatomyositis * Scleroderma * Multiple sclerosis * Juvenile-onset insulin-dependent diabetes * active infection * fever * allergy to study reagents * pregnant or nursing * other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix * unstable or severe medical or psychiatric condition, as determined by the investigator * underlying condition that would preclude study participation * concurrent radiotherapy * prior organ allograft * concurrent strong painkillers * other concurrent immune-suppressing medications * other concurrent investigational agents * other adjuvant treatment for 4 weeks\* after the final dose of study vaccine NOTE: \*Unless there is evidence of tumor progression necessitating additional clinically-indicated treatment; patients requiring treatment due to tumor progression are removed from the study
References
Publications (0)
Data not yet available