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NCT01204684 · ClinicalTrials.gov registry record · Phase 2

Dendritic Cell Vaccine for Patients With Brain Tumors

A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target

NCT01204684 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 24 participants.

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The verdict

NCT01204684, a Phase 2 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.

Interventions

  • BIOLOGICAL autologous tumor lysate-pulsed DC vaccination
  • BIOLOGICAL Tumor lysate-pulsed DC vaccination+0.2% resiquimod
  • BIOLOGICAL Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-10-08
Est. Completion 2024-08-21
Phase Phase 2

Sponsor

Jonsson Comprehensive Cancer Center

321 total trials

What the Registry Record Tells You About NCT01204684

The ClinicalTrials.gov registry entry for NCT01204684 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which autologous tumor lysate-pulsed DC vaccination is the first listed.

NCT01204684 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01204684 about?

NCT01204684 is a clinical study titled "Dendritic Cell Vaccine for Patients With Brain Tumors". The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an in...

What is the current status of trial NCT01204684?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-10-08. Estimated completion is 2024-08-21.

What interventions are being tested in trial NCT01204684?

The interventions under investigation include: autologous tumor lysate-pulsed DC vaccination (BIOLOGICAL), Tumor lysate-pulsed DC vaccination+0.2% resiquimod (BIOLOGICAL), Tumor-lysate pulsed DC vaccination +adjuvant polyICLC (BIOLOGICAL).

Who is sponsoring clinical trial NCT01204684?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.