Study Summary
This trial is testing a new vaccine for people with glioblastoma. The goal is to see if it is safe and if it helps people live longer.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Two years
Year 2
Overall survival of patients receiving Th-1 dendritic cell immunotherapy
Progression-free survival of patients receiving Th-1 dendritic cell immunotherapy
Two years
Safety and potential toxicity of Th-1 dendritic cell immunotherapy
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Dendritic cell vaccine dose escalation two
1 of 4
Dendritic cell vaccine dose escalation one
1 of 4
Dendritic cell vaccine: Starting dose
1 of 4
Dendritic cell vaccine dose de-escalation
1 of 4
Experimental Treatment
24 Total Participants · 4 Treatment Groups
Primary Treatment: TH-1 Dendritic Cell Immunotherapy · No Placebo Group · Phase 1
Dendritic cell vaccine dose escalation two
Biological
Experimental Group · 1 Intervention: TH-1 Dendritic Cell Immunotherapy · Intervention Types: BiologicalDendritic cell vaccine dose escalation one
Biological
Experimental Group · 1 Intervention: TH-1 Dendritic Cell Immunotherapy · Intervention Types: BiologicalDendritic cell vaccine: Starting dose
Biological
Experimental Group · 1 Intervention: TH-1 Dendritic Cell Immunotherapy · Intervention Types: BiologicalDendritic cell vaccine dose de-escalation
Biological
Experimental Group · 1 Intervention: TH-1 Dendritic Cell Immunotherapy · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: two years
Who is running the clinical trial?
Baylor College of MedicineOTHER
923 Previous Clinical Trials
5,987,989 Total Patients Enrolled
3 Trials studying Glioblastoma
56 Patients Enrolled for Glioblastoma
Philadelphia College of Osteopathic MedicineOTHER
5 Previous Clinical Trials
927 Total Patients Enrolled
The Cooper Health SystemLead Sponsor
64 Previous Clinical Trials
21,023 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Any person, male or female, who is 18 years old or older can participate.
When your ANC is 1,500 cells/mm3 or more, you are considered to have a normal neutrophil count.
The tumor board has decided to allow the patient to enroll in the trial.
Patients who have been diagnosed with a glioblastoma tumor that is potentially resectable, and who are deemed to be good candidates for postoperative adjuvant chemo and radiation therapy, may include patients whose tumors are deemed suitable for gross total resection, as well as patients whose tumors are deemed partially resectable and who undergo partial resection followed by adjuvant therapy.
may limit vaccine efficacy
If you are unable to adhere to the bi-weekly injections required by the DC vaccine regimen, the vaccine may not be as effective.
For women of reproductive potential: use contraception during the study and for 12 weeks after the final dose of the vaccine
For men who could potentially father a child, they must use condoms or another form of contraception with their partner during the study and for an additional 12 weeks after stopping the last dose of the vaccine.
I agree to comply with all study procedures and will be available for the duration of the study.
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Conditions
Cancer Related
Treatments