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A Phase l Trial of Surgical Resection With Gliadel Wafer Placement Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate for Patients With Malignant Glioma


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Glioma

Thank you

Trial Information

A Phase l Trial of Surgical Resection With Gliadel Wafer Placement Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate for Patients With Malignant Glioma


Inclusion Criteria:



- Patients must have a histopathological diagnosis of malignant glioma

- Patients must have undergone surgery and placement of Gliadel wafer.

- Women of child bearing potential must use medically accepted form of birth control.

- A Karnofsky performance status of at least 60%

- Must be off of steroid at least two weeks prior to vaccination

- Hematologic and metabolic panel results will be within the parameters of the
protocol.

- Must be capable of IRB approved Informed Consent.

Exclusion Criteria:

- Patients with systemic disease

- Presence of acute infection

- Contraindication to MRI

- Known history of autoimmune disorder

- Pregnancy

- Positive for hepatitis B, C, HIV, syphilis, HTLVa nd HCV

- Allergic to Gentamicin.

- Inability to participate as per Principal Investigator's discretion.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the survival of malignant glioma a, to assess the immunogeneicity of patients who receive Dendritic cell vaccine , to assess progression free survival and to evaluate quality of life.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

John Yu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

9789

NCT ID:

NCT00576446

Start Date:

April 2007

Completion Date:

May 2012

Related Keywords:

  • Malignant Glioma
  • Glioma

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804