Vaccine Therapy in Treating Patients With Malignant Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00068510
First received: September 10, 2003
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: therapeutic autologous dendritic cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- Dose Limiting Toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 18 |
| Study Start Date: | June 2003 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: autologous tumor lysate-pulsed DC | Biological: therapeutic autologous dendritic cells |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068510
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Principal Investigator: | Linda M. Liau, MD, PhD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00068510 History of Changes |
| Other Study ID Numbers: | CDR0000327711, P30CA016042, UCLA-0304053 |
| Study First Received: | September 10, 2003 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
adult glioblastoma adult anaplastic astrocytoma adult brain tumor |
adult giant cell glioblastoma adult gliosarcoma adult anaplastic oligodendroglioma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Site Neoplasms Nervous System Diseases |
Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013