Clinical trial · Interventional
Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
A Phase I Trial of Surgical Resection Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate With Imiquimod for Patients With Malignant Glioma
- 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)
Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 24 months. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain (i.e., young) patient subpopulations. Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells are foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell (DC) vaccines.
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 |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic Cell Vaccine in combination with Imiquimod cream | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological/Vaccine
- interventionNames
- Biological: Dendritic Cell Vaccine in combination with Imiquimod cream
Primary outcomes (1)
- measure
- safety of an autologous tumor lysate- loaded dendritic cell (DC) vaccine with Imiquimod cream application
- timeFrame
- 1 year
- description
- Safety relative to vaccine will be monitored in terms of Serious Adverse Events according to FDA regulations and recorded on a MedWatch 3500a form. A Data Safety Monitoring Committee will meet every 6 months to review AEs/SAE's. In the event of any subject death within a 30 day period following study agent administration, the DSMC will review the death within that time frame. If two deaths are deemed to be "probably" or "definitely' related to study agent administration, all study agent administrations will be stopped and the FDA and IRB will be notified of study cessation.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histopathological diagnosis of malignant glioma. * Patients 18 years of age or older. * Patients must have undergone maximal surgical resection of malignant glioma * Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female. * Patients must have a Karnofsky performance score of at least 60%. * Patients must be off steroids for at least two weeks prior to vaccination. * Baseline hematologic and complete metabolic panel within one week of initiating therapy must fall within normal ranges * Patient must be capable of signing IRB approved Research Consent and Release of Medical Records form. Exclusion Criteria: * Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk. * The presence of an acute infection requiring active treatment will be criteria for delay or exclusion. * Contraindication to MRI procedure unless otherwise determined by PI. * Patients with a known history of an autoimmune disorder. * Pregnancy. * Patients positive for hepatitis B, hepatitis C, HIV I/II, syphilis, HTLV I/II, HCV. * Patients with allergy to Gentamicin. * Patient inability to participate as determined by PI discretion.
References
Publications (0)
Data not yet available