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Vaccine Therapy in Treating Patients With Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
therapeutic autologous dendritic cells
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult anaplastic astrocytoma, adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic oligodendroglioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous tumor lysate-pulsed DC

Arm Description

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2003
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00068510
Brief Title
Vaccine Therapy in Treating Patients With Malignant Glioma
Official Title
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult anaplastic astrocytoma, adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic oligodendroglioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
autologous tumor lysate-pulsed DC
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda M. Liau, MD, PhD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16061868
Citation
Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25. doi: 10.1158/1078-0432.CCR-05-0464.
Results Reference
result
PubMed Identifier
23377664
Citation
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.
Results Reference
derived

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Vaccine Therapy in Treating Patients With Malignant Glioma

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