NCT00612001

Brief Summary

RATIONALE: Vaccines made from peptides and a person's 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 and best dose of vaccine therapy in treating patients with malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2006

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

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 5, 2015

Status Verified

August 1, 2013

Enrollment Period

4.7 years

First QC Date

February 8, 2008

Last Update Submit

October 1, 2015

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytomaadult glioblastomaadult giant cell glioblastomaadult gliosarcomaadult anaplastic oligodendrogliomarecurrent adult brain tumoradult mixed glioma

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides

    3 months

  • Survival

    1 year

  • Tumor progression

    1 year

Study Arms (1)

dendritic cell vaccine

EXPERIMENTAL
Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Interventions

glioma-associated antigen peptide-pulsed autologous dendritic cell vaccineBIOLOGICAL
dendritic cell vaccine

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of 1 of the following malignant gliomas:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Oligodendroglioma
  • Oligoastrocytoma
  • WHO grade III or IV disease
  • Newly diagnosed or recurrent disease
  • Bidimensionally measurable disease by contrast-enhancing MRI
  • Surgically accessible tumor for which resection is indicated
  • Previously treated with or planning to undergo treatment with conventional external beam radiotherapy
  • HLA-A\*201 positive
  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 8 weeks
  • Hemoglobin ≥ 10 g/dL
  • Absolute granulocyte count ≥ 1,500/mm³
  • +12 more criteria

You may not qualify if:

  • active infection
  • immunodeficiency
  • autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Vasculitis
  • Polymyositis-dermatomyositis
  • Scleroderma
  • Multiple sclerosis
  • Juvenile-onset insulin-dependent diabetes
  • allergy to study agents
  • underlying condition that would contraindicate study therapy
  • concurrent severe or unstable medical condition that would preclude giving informed consent
  • psychiatric condition that would preclude study participation or giving informed consent
  • other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Prins RM, Wang X, Soto H, Young E, Lisiero DN, Fong B, Everson R, Yong WH, Lai A, Li G, Cloughesy TF, Liau LM. Comparison of glioma-associated antigen peptide-loaded versus autologous tumor lysate-loaded dendritic cell vaccination in malignant glioma patients. J Immunother. 2013 Feb;36(2):152-7. doi: 10.1097/CJI.0b013e3182811ae4.

    PMID: 23377664DERIVED

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaGlioblastomaGliosarcomaOligodendrogliomaBrain NeoplasmsGlioma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Linda M. Liau, MD, PhD

    Jonsson Comprehensive Cancer Center

    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

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 11, 2008

Study Start

May 1, 2006

Primary Completion

January 1, 2011

Study Completion

October 1, 2012

Last Updated

October 5, 2015

Record last verified: 2013-08

Locations

US(1)