MedTrace Logo

Study of DC Vaccination Against Glioblastoma

NCT01567202 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-09-09

No results posted yet for this study

Summary

This is a Phase II study in a single center to determine the efficacy of autologous dendritic cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a vaccination in adults with glioblastoma multiforme (primary or secondary).

Conditions

Interventions

PROCEDURE

Surgery

Maximum resection of the tumor (≥95%) with the help of conventional or intraoperative MRI neuronavigation. Confirmation will be proceeded by the contrast MRI within 72 hours after surgery.

DRUG

Chemotherapy

Temozolomide(TMZ), 200mg·m\^-2·d ×5 days，28 days every cycle. 6 cycles of TMZ are recommended.

RADIATION

Radiotherapy

Standard dose, 4500 cGy to tumor with 3-cm margins, 1500 cGy boost to tumor bed.

BIOLOGICAL

DC vaccination

Eight to ten million dendritic cells (DCs) - administered via intradermal injections in 0.5 ml Phosphate Buffered Saline (PBS) in the shoulders near the back of the neck to facilitate trafficking of the DCs to the cervical lymph nodes.

DRUG

blank placebo

Saline that has the same appearance with DC vaccine.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Liangfu Zhou, M.D. · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2020-11-01
Completion
2021-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT01567202 on ClinicalTrials.gov