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Cancer Vaccine
Dendritic Cell Vaccine for Brain Tumor
Phase 1
Waitlist Available
Research Sponsored by Macarena De La Fuente, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 80 (5 years post therapy)
Awards & highlights
Study Summary
This study is evaluating whether a vaccine can be used to treat brain tumors.
Eligible Conditions
- Brain Tumor
- Malignant Glioma
- Glioblastoma
- Anaplastic Astrocytoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 80 (5 years post therapy)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 80 (5 years post therapy)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Treatment-Related Adverse Events
Secondary outcome measures
Change in MDSC Levels
Change in blood counts
Comparison of clinical parameters associated with outcomes in study participants to patients on other DC/Imiquimod studies.
+3 moreSide effects data
From 2013 Phase 2 trial • 11 Patients • NCT0032311510%
Pain, neck, unilateral, Grade 2
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vaccine
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety Pilot: DC Vaccine/LysateExperimental Treatment4 Interventions
Participants in this group will undergo leukapheresis after standard of care surgical tumor resection. Leukapheresis will be used to obtain peripheral blood mononuclear cells (PBMC) from which the dendritic cells (DC) will be obtained. Retrieved DC will be used as a vaccine once weekly on Weeks 1-4 within 3 weeks from end of leukapheresis. Participants will also receive Imiquimod, which will be applied one evening prior to DC dose for 8 hours then for 8 hours each of the next two evenings. Enrollment of participants in the Pilot group will be staggered until the second participant has no treatment limiting toxicities. For the first five subjects to be enrolled in the pilot, the administration of DC to each subject will be delayed until the prior subject has received the second administration of DC. Participants will also receive Lysate of tumor administered every 4 weeks + 3 days on Weeks 8, 12, 16 and 28 (+ / - 3 days).
Group II: Expansion Cohort: DC Vaccine/LysateExperimental Treatment4 Interventions
Participants in this group will undergo leukapheresis within after standard of care surgical tumor resection. Leukapheresis will be used to obtain peripheral blood mononuclear cells (PBMC) from which the dendritic cells (DC) will be obtained. Retrieved DC will be used as a vaccine once weekly on Weeks 1-4 within 3 weeks from end of pheresis. Participants will also receive Imiquimod, which will be applied one evening prior to DC dose for 8 hours then for 8 hours each of the next two evenings. Participants will also receive Lysate of tumor administered every 4 weeks + 3 days on Weeks 8, 12, 16 and 28 (+ / - 3 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leukapheresis
2016
Completed Phase 2
~690
Dendritic Cell Vaccine
2011
Completed Phase 2
~140
Imiquimod
2005
Completed Phase 4
~2260
Tumor Lysate
2013
Completed Phase 1
~20
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Who is running the clinical trial?
Macarena De La Fuente, MDLead Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled
Frequently Asked Questions
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