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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

glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dendritic cell vaccine

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides

Survival

Tumor progression

Secondary Outcome Measures

Full Information

NCT ID

NCT00612001

First Posted

February 8, 2008

Last Updated

October 1, 2015

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00612001

Brief Title

Vaccine Therapy in Treating Patients With Malignant Glioma

Official Title

Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 anaplastic astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult mixed glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dendritic cell vaccine

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Primary Outcome Measure Information:

Title

Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides

Time Frame

3 months

Title

Survival

Time Frame

1 year

Title

Tumor progression

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

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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