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Vaccine Therapy in Treating Patients With Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00612001
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE February 8, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date October 5, 2015
Study Start Date  ICMJE May 2006
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides [ Time Frame: 3 months ]
  • Survival [ Time Frame: 1 year ]
  • Tumor progression [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2008)
  • Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides
  • Survival
  • Tumor progression
  • Cellular immune response
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Malignant Glioma
Official Title  ICMJE Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
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.

Detailed Description

OBJECTIVES:

  • Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with malignant gliomas.
  • Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.

OUTLINE: Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF) and interleukin-4 (IL-4), matured with a cytokine cocktail, and pulsed with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum tolerated dose is determined.

After completion of study treatment, patients are followed every 2 months for 1 year.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
Study Arms  ICMJE Experimental: dendritic cell vaccine
Intervention: Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2011)
8
Original Enrollment  ICMJE
 (submitted: February 8, 2008)
18
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Platelet count ≥ 100,000/mm³
  • SGOT and SGPT ≤ 2 times normal
  • Alkaline phosphatase ≤ 2 times normal
  • Bilirubin ≤ 1.5 mg/dL
  • BUN ≤ 1.5 times normal OR creatinine ≤ 1.5 times normal
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hepatitis B negative
  • Hepatitis C negative
  • HIV negative
  • Syphilis serology negative
  • Afebrile

Exclusion Criteria:

  • 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
  • prior chemotherapy (6 weeks for nitrosoureas) within last 4 weeks of starting treatment
  • concurrent corticosteroids within 2 weeks prior to treatment
  • radiotherapy within 2 weeks prior to treatment
  • systemic antibiotics within 72 hours prior to treatment
  • prior organ allograft
  • antihistamine therapy within 5 days before or after administration of study vaccine
  • chemotherapy during and for 4 weeks after administration of study vaccine
  • adjuvant therapy during and for 4 weeks after administration of study vaccine
  • other concurrent investigational agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00612001
Other Study ID Numbers  ICMJE CDR0000585166
R01CA112358 ( U.S. NIH Grant/Contract )
UCLA-06-01-052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Linda M. Liau, MD, PhD Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP