NCT00890032

Brief Summary

RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

5.1 years

First QC Date

April 28, 2009

Last Update Submit

October 13, 2016

Conditions

Recurrent Central Nervous System Neoplasm

Keywords

adult giant cell glioblastomaadult glioblastomaadult gliosarcomaadult astrocytomarecurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

  • Feasibility and safety

    12 months

Secondary Outcomes (1)

  • Humoral and cellular immune responses

    12 months

Study Arms (1)

BTSC mRNA-loaded DCs

EXPERIMENTAL

BTSC mRNA-loaded DCs administered intradermally weekly for first 3 vaccines, then monthly until progression or withdrawal.

Biological: BTSC mRNA-loaded DCs

Interventions

BTSC mRNA-loaded DCsBIOLOGICAL

An escalating total dose of BTSC mRNA-loaded DCs (2x10\^6, 5x10\^6, and 2x10\^7 per vaccination) will be evaluated for purpose of establishing a maximum tolerated dose (MTD) and a dose-limiting toxicity (DLT).

BTSC mRNA-loaded DCs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years of age
  • First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of GBM
  • No known contraindications to receiving Avastin
  • Karnofsky Performance Status (KPS) of \> 70%
  • Radiation Therapy (RT) with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry

You may not qualify if:

  • Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)
  • Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
  • Pregnant or need to breast feed during the study period (Negative beta-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study
  • Active infection requiring treatment or an unexplained febrile (\> 101.5 degrees F) illness
  • Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C
  • Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 \< 50%) disease, uncontrolled diabetes mellitus
  • Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery
  • Prior inguinal lymph node dissection
  • Subjects meeting any of the following criteria are ineligible for study entry:
  • Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to enrollment
  • History of stroke or transient ischemic attack within 6 months prior to enrollment
  • Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcomaAstrocytomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Gordana Vlahovic, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2014

Study Completion

February 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)