Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Malignant Glioma
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
NCT00068510CI-TRIAL-00046364completedPhase 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 a person's white blood cells mixed with tumor proteins may make the body build an 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 |
|---|---|---|---|
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- autologous tumor lysate-pulsed DC
- interventionNames
- Biological: therapeutic autologous dendritic cells
Primary outcomes (1)
- measure
- Dose Limiting Toxicity
- timeFrame
- 4 weeks
Secondary outcomes (1)
- measure
- Time to tumor progression, overall survival and cellular immune responses in brain tumor patients injected with tumor lysate pulsed dendritic cells
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria: * Histologically confirmed diagnosis of one of the following malignant gliomas: * Anaplastic astrocytoma * Glioblastoma multiforme * Anaplastic oligodendroglioma * Malignant mixed oligoastrocytoma * WHO grade III or IV disease * Newly diagnosed disease * Bidimensionally measurable disease by contrast-enhancing MRI * Surgically accessible tumor for which resection is indicated * Previously treated with or plan to undergo treatment with conventional external beam radiotherapy * Age 18 and over * Performance status Karnofsky 60-100% * Life expectancy at least 8 weeks * Hemoglobin at least 10 g/dL * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * SGOT and SGPT no greater than 2 times normal * Alkaline phosphatase no greater than 2 times normal * Bilirubin no greater than 1.5 mg/dL * Hepatitis B negative * Hepatitis C negative * BUN no greater than 1.5 times normal * Creatinine no greater than 1.5 times normal * HIV negative * Syphilis serology negative * Afebrile * Negative pregnancy test * Fertile patients must use effective contraception * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered. * At least 2 weeks since prior corticosteroids * At least 2 weeks since prior radiotherapy and recovered * More than 72 hours since prior systemic antibiotics 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 * pregnant or nursing * 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 * concurrent chemotherapy during and for 2 weeks after administration of study vaccine * concurrent corticosteroids prior organ allograft * antihistamine therapy within 5 days before or after administration of study vaccine * other concurrent investigational agents * concurrent adjuvant therapy during and for 2 weeks after administration of study vaccine
References
Publications (2)
- RESULTLiau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25. doi: 10.1158/1078-0432.CCR-05-0464. PMID 16061868
- 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