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Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00639639 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-03-13

No results posted yet for this study

Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with radiation therapy and chemotherapy may kill more cancer cells.

PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia caused by temozolomide.

Conditions

  • Malignant Neoplasms of Brain

Interventions

BIOLOGICAL

tetanus toxoid

Given by injection

BIOLOGICAL

therapeutic autologous dendritic cells

Given intradermally

BIOLOGICAL

therapeutic autologous lymphocytes

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gary Archer Ph.D.

    lead OTHER

Principal Investigators

  • Katherine Peters, MD, PhD · Duke Univeristy Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-06
Primary Completion
2017-04-15
Completion
2022-06-01

Countries

  • United States

Study Locations

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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 NCT00639639 on ClinicalTrials.gov