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Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma

NCT01808820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-20

No results posted yet for this study

Summary

The purpose of this research study is to evaluate an investigational vaccine using patent-derived dendritic cells (DC) to treat malignant glioma or glioblastoma.

Conditions

Interventions

BIOLOGICAL

Dendritic Cell Vaccine

Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.

BIOLOGICAL

Tumor Lysate

Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.

DRUG

Imiquimod

5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate

PROCEDURE

Leukapheresis

Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.

Sponsors & Collaborators

  • Macarena De La Fuente, MD

    lead OTHER

Principal Investigators

  • Macarena De La Fuente, MD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-21
Primary Completion
2018-11-07
Completion
2022-07-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808820 on ClinicalTrials.gov