Vaccine Therapy in Treating Patients With Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00068510
First received: September 10, 2003
Last updated: August 22, 2013
Last verified: August 2013

September 10, 2003
August 22, 2013
June 2003
September 2012   (final data collection date for primary outcome measure)
Dose Limiting Toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00068510 on ClinicalTrials.gov Archive Site
Time to tumor progression, overall survival and cellular immune responses in brain tumor patients injected with tumor lysate pulsed dendritic cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients With Malignant Glioma
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an 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.

OBJECTIVES:

  • Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor lysate-pulsed dendritic cells in patients with malignant gliomas.
  • Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

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 and pulsed with autologous tumor lysate. Patients receive autologous tumor lysate-pulsed DC intradermally on days 0, 14, and 28 in the absence of unacceptable toxicity.

Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18 months.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Biological: therapeutic autologous dendritic cells
Experimental: autologous tumor lysate-pulsed DC
Intervention: Biological: therapeutic autologous dendritic cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2012
September 2012   (final data collection date for primary outcome measure)

Eligibility Criteria:

  • Histologically confirmed diagnosis of one of the following malignant gliomas:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Anaplastic oligodendroglioma
  • Malignant mixed oligoastrocytoma
  • WHO grade III or IV disease
  • Newly diagnosed disease
  • Bidimensionally measurable disease by contrast-enhancing MRI
  • Surgically accessible tumor for which resection is indicated
  • Previously treated with or plan to undergo treatment with conventional external beam radiotherapy
  • Age 18 and over
  • Performance status Karnofsky 60-100%
  • Life expectancy at least 8 weeks
  • Hemoglobin at least 10 g/dL
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • SGOT and SGPT no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal
  • Bilirubin no greater than 1.5 mg/dL
  • Hepatitis B negative
  • Hepatitis C negative
  • BUN no greater than 1.5 times normal
  • Creatinine no greater than 1.5 times normal
  • HIV negative
  • Syphilis serology negative
  • Afebrile
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered.
  • At least 2 weeks since prior corticosteroids
  • At least 2 weeks since prior radiotherapy and recovered
  • More than 72 hours since prior systemic antibiotics

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
  • pregnant or nursing
  • 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
  • concurrent chemotherapy during and for 2 weeks after administration of study vaccine
  • concurrent corticosteroids prior organ allograft
  • antihistamine therapy within 5 days before or after administration of study vaccine
  • other concurrent investigational agents
  • concurrent adjuvant therapy during and for 2 weeks after administration of study vaccine
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068510
CDR0000327711, P30CA016042, UCLA-0304053
Yes
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Linda M. Liau, MD, PhD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
August 2013

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