NCT00107185

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2012

Enrollment Period

4.8 years

First QC Date

April 5, 2005

Last Update Submit

August 3, 2020

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood high-grade cerebral astrocytomarecurrent childhood cerebral astrocytomachildhood oligodendroglioma

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.

    1 year

Secondary Outcomes (1)

  • survival

    1 year

Other Outcomes (1)

  • time to progression

    1 year

Study Arms (1)

Vaccine

EXPERIMENTAL
Biological: therapeutic autologous dendritic cells

Interventions

therapeutic autologous dendritic cellsBIOLOGICAL
Vaccine

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed\* WHO grade III or IV malignant glioma of 1 of the following subtypes:
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme NOTE: \*Must be confirmed after surgery
  • Newly diagnosed OR recurrent disease
  • Bidimensionally measurable disease by contrast-enhancing pre-operative MRI
  • Surgically accessible tumor for which surgical resection is indicated at the time of initial pre-operative evaluation
  • Must have undergone standard surgery\* AND either radiotherapy\* or chemoradiotherapy\*
  • Objective evidence of disease by contrast-enhanced brain MRI after completion of standard therapy NOTE: \*Completed after study entry but before assignment to study treatment cohorts
  • Age 1 to 18
  • Performance status Karnofsky 60-100%
  • Hematopoietic
  • Hemoglobin ≥ 10 g/dL
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • +20 more criteria

You may not qualify if:

  • history of immunodeficiency or 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
  • active infection
  • fever
  • allergy to study reagents
  • pregnant or nursing
  • 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
  • unstable or severe medical or psychiatric condition, as determined by the investigator
  • +7 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

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaOligodendroglioma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joseph L. Lasky, MD

    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

April 5, 2005

First Posted

April 6, 2005

Study Start

January 1, 2005

Primary Completion

October 1, 2009

Study Completion

March 1, 2010

Last Updated

August 5, 2020

Record last verified: 2012-08

Locations

US(1)