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Cancer Vaccine
Dendritic Cell Vaccine for Glioblastoma
Phase 1
Waitlist Available
Led By Ashley Ghiaseddin, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up leukapheresis to investigational product release date or up to 6 weeks
Awards & highlights
Study Summary
This trial is looking at whether it's possible to generate an investigational vaccine for patients with brain cancer who have already started chemotherapy.
Who is the study for?
Adults over 18 with newly diagnosed Glioblastoma who've finished radiation and are on Temozolomide therapy can join. They need a Karnofsky score of at least 70, stable steroid doses, good organ function, and no severe illnesses or prior invasive cancers (except skin cancer) in the last 3 years. Women must not be pregnant and participants must use contraception.Check my eligibility
What is being tested?
The trial is testing a personalized vaccine made from patients' own immune cells loaded with CMV RNA to treat Glioblastoma. It's for those who have completed initial treatment and are now on maintenance chemotherapy.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation, flu-like symptoms due to GM-CSF, fatigue, injection site reactions, and potential complications from drawing blood to make the vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ leukapheresis to investigational product release date or up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~leukapheresis to investigational product release date or up to 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to generate CMV pp65 RNA-pulsed DCs in patients receiving adjuvant temozolomide chemotherapy after radiotherapy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Autologous DCs derived from PBMC loaded with RNAExperimental Treatment1 Intervention
Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,349 Previous Clinical Trials
719,894 Total Patients Enrolled
11 Trials studying Glioblastoma
501 Patients Enrolled for Glioblastoma
Immunomic Therapeutics, Inc.Industry Sponsor
8 Previous Clinical Trials
470 Total Patients Enrolled
2 Trials studying Glioblastoma
185 Patients Enrolled for Glioblastoma
Ashley Ghiaseddin, MDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
94 Total Patients Enrolled
3 Trials studying Glioblastoma
82 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious and ongoing health condition.You had an allergic reaction to TMZ, GM-CSF, or Td vaccines before.You have a severe lung disease that has recently gotten worse and requires hospitalization or makes it impossible to start the study treatment.The disease has come back after previous treatment.You have taken a new, unapproved medication within the past 28 days before starting the study.The tumor must be located in the upper part of the brain.You are currently receiving additional treatment called Temozolomide.You have a condition that weakens your immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous DCs derived from PBMC loaded with RNA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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