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Cancer Vaccine

Dendritic Cell Vaccine for Glioblastoma

Phase 1
Waitlist Available
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with glioblastoma (GBM) deemed to be potentially resectable and who are deemed to be good candidate for postoperative adjuvant chemo and radiation therapy. This 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. [neoadjuvant therapy is rarely if ever given]..
Ability to adhere to the bi-weekly injections of DC vaccine regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum 2 years from time of diagnosis
Awards & highlights

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.

Who is the study for?
Adults aged 18+ with glioblastoma that can potentially be removed by surgery and are good candidates for post-surgery chemo and radiation. They must commit to bi-weekly vaccine injections, use effective contraception, have a negative pregnancy test (if applicable), and have proper kidney, liver, bone marrow, and immune function.Check my eligibility
What is being tested?
This phase I trial tests the safety of a new dendritic-cell vaccine given after standard treatments for glioblastoma. It also looks at how long patients live without their cancer getting worse and overall survival rates.See study design
What are the potential side effects?
Specific side effects aren't listed here but generally could include reactions at the injection site, flu-like symptoms such as fever or fatigue due to immune system activation, or other unforeseen responses related to individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be able to follow the bi-weekly schedule for receiving DC vaccine injections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and potential toxicity of Th-1 dendritic cell immunotherapy
Secondary outcome measures
Overall survival of patients receiving Th-1 dendritic cell immunotherapy
Progression-free survival of patients receiving Th-1 dendritic cell immunotherapy

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dendritic cell vaccine: Starting doseExperimental Treatment1 Intervention
This arm will evaluate the safety of administering a total dendritic cell dose of 3.5 x 10^6. A total of 3-6 patients will be enrolled with this dose. If this dose is associated with unacceptable side effects, as detailed in the study protocol, no further patients will be enrolled at this dose.
Group II: Dendritic cell vaccine dose escalation twoExperimental Treatment1 Intervention
If no unacceptable side effects, as detailed in the study protocol, are identified at a total dose of 7.0 x 10^6, then a cohort of 3-6 enrolled patients will receive an escalated total dendritic cell dose of 1.4 X 10^7.
Group III: Dendritic cell vaccine dose escalation oneExperimental Treatment1 Intervention
If no unacceptable side effects, as detailed in the study protocol, are identified at a total dose of 3.5 x 10^6, then a cohort of 3-6 enrolled patients will receive an escalated total dendritic cell dose of 7.0 X 10^6.
Group IV: Dendritic cell vaccine dose de-escalationExperimental Treatment1 Intervention
If unacceptable side effects, as detailed in the study protocol, are identified at a total dose of 3.5 x 10^6, then a cohort of 3-6 enrolled patients will receive a de-escalated total dendritic cell dose of 1.75 X 10^6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TH-1 Dendritic Cell Immunotherapy
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
75 Previous Clinical Trials
24,132 Total Patients Enrolled
Baylor College of MedicineOTHER
997 Previous Clinical Trials
6,002,057 Total Patients Enrolled
3 Trials studying Glioblastoma
56 Patients Enrolled for Glioblastoma
Philadelphia College of Osteopathic MedicineOTHER
8 Previous Clinical Trials
1,025 Total Patients Enrolled

Media Library

TH-1 Dendritic Cell Immunotherapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04552886 — Phase 1
Glioblastoma Research Study Groups: Dendritic cell vaccine dose escalation one, Dendritic cell vaccine dose escalation two, Dendritic cell vaccine: Starting dose, Dendritic cell vaccine dose de-escalation
Glioblastoma Clinical Trial 2023: TH-1 Dendritic Cell Immunotherapy Highlights & Side Effects. Trial Name: NCT04552886 — Phase 1
TH-1 Dendritic Cell Immunotherapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04552886 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an experimental or untested trial?

"Currently, there are 3 ongoing TH-1 Dendritic Cell Immunotherapy trials in 74 cities and 5 countries. This therapeutic area was first explored 14 years ago when Northwest Biotherapeutics launched a Phase 3 drug approval study involving 348 patients. Since then, an additional 4 studies have been concluded."

Answered by AI

Is enrollment for this experiment still open?

"Affirmative, this clinical trial is actively recruiting according to information provided on the clinicaltrials.gov website. The research began recruitment on October 11th 2021 and was last amended June 27th 2022, aiming to enrol 24 participants from 2 medical centres."

Answered by AI

Has TH-1 Dendritic Cell Immunotherapy been studied previously?

"Presently, 3 clinical trials are examining the efficacy of TH-1 Dendritic Cell Immunotherapy one of which has reached Phase 3. Primarily situated in Camden, New jersey, 91 centres across the country have launched studies on this form of treatment."

Answered by AI

Could you please explain the potential risks associated with TH-1 Dendritic Cell Immunotherapy?

"The safety of TH-1 Dendritic Cell Immunotherapy is estimated to be a 1 due to the limited evidence on its efficacy and safety, as this is still an early phase trial."

Answered by AI

To what extent is this medical study examining a population of participants?

"Affirmative. Clinicaltrials.gov indicates that this study was listed on October 11th 2021 and has been actively recruiting since then. The 24 participants required are to be drawn from two distinct medical sites."

Answered by AI
~5 spots leftby Mar 2025