Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Malignant Glioma
Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
NCT00612001CI-TRIAL-00019325completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with 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 |
|---|---|---|---|
| glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dendritic cell vaccine
- interventionNames
- Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
Primary outcomes (3)
- measure
- Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides
- timeFrame
- 3 months
- measure
- Survival
- timeFrame
- 1 year
- measure
- Tumor progression
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of 1 of the following malignant gliomas: * Anaplastic astrocytoma * Glioblastoma multiforme * Oligodendroglioma * Oligoastrocytoma * WHO grade III or IV disease * Newly diagnosed or recurrent disease * Bidimensionally measurable disease by contrast-enhancing MRI * Surgically accessible tumor for which resection is indicated * Previously treated with or planning to undergo treatment with conventional external beam radiotherapy * HLA-A\*201 positive * Karnofsky performance status 60-100% * Life expectancy ≥ 8 weeks * Hemoglobin ≥ 10 g/dL * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * SGOT and SGPT ≤ 2 times normal * Alkaline phosphatase ≤ 2 times normal * Bilirubin ≤ 1.5 mg/dL * BUN ≤ 1.5 times normal OR creatinine ≤ 1.5 times normal * Negative pregnancy test * Fertile patients must use effective contraception * Hepatitis B negative * Hepatitis C negative * HIV negative * Syphilis serology negative * Afebrile Exclusion Criteria: * active infection * immunodeficiency * 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 * allergy to study agents * underlying condition that would contraindicate study therapy * concurrent severe or unstable medical condition that would preclude giving informed consent * psychiatric condition that would preclude study participation or giving informed consent * 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 * prior chemotherapy (6 weeks for nitrosoureas) within last 4 weeks of starting treatment * concurrent corticosteroids within 2 weeks prior to treatment * radiotherapy within 2 weeks prior to treatment * systemic antibiotics within 72 hours prior to treatment * prior organ allograft * antihistamine therapy within 5 days before or after administration of study vaccine * chemotherapy during and for 4 weeks after administration of study vaccine * adjuvant therapy during and for 4 weeks after administration of study vaccine * other concurrent investigational agents
References
Publications (1)
- DERIVEDPrins RM, Wang X, Soto H, Young E, Lisiero DN, Fong B, Everson R, Yong WH, Lai A, Li G, Cloughesy TF, Liau LM. Comparison of glioma-associated antigen peptide-loaded versus autologous tumor lysate-loaded dendritic cell vaccination in malignant glioma patients. J Immunother. 2013 Feb;36(2):152-7. doi: 10.1097/CJI.0b013e3182811ae4. PMID 23377664