Vaccine Therapy in Treating Patients With Malignant Glioma

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Biological: therapeutic autologous dendritic cells

• Registration Number: NCT00068510
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-08
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous tumor lysate-pulsed DC	therapeutic autologous dendritic cells	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	4 weeks

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression, overall survival and cellular immune responses in brain tumor patients injected with tumor lysate pulsed dendritic cells	2 years

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States