Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

Glioblastoma Clinical Trial

Official title:

Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576537
• Other study ID #: 3368
• Status: Completed
• Phase: Phase 2
• Start date: March 2001
• Est. completion date: October 2011

Study information

• Verified date: April 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.

Description:

To become eligible for therapy the following criteria must be fulfilled:

• No age or gender limit

• Patients with atypical malignant brain tumors.

• Must have a Karnofsky performance of at least 60%

• Hematologic studies and chemistry profiles will be within the parameters of the protocol

• Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.

• Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.

• Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.

• patients with atypical malignant brain tumor will be eligible.

• Patients must have a Karnofsky performance score of at least 60%

• patients may be maintained on glucocorticoid therapy at the lowest possible dose.

• Baseline hematologic studies and chemistry profiles must meet the criteria.

• Tumor specimen of adequate size to yield protein concentration in sufficient quantity.

• Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.

• Patient must have no prior sensitivity to the components of the dendritic cell vaccine.

• Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.

• Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.

Exclusion Criteria:

• Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.

• The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.

• Patients with a known history of an autoimmune disorder.

• Inability to give informed consent.

• Pregnancy.

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioblastoma

Intervention

Biological:
• Dendritic Cell Immunotherapy
Patients will receive four vaccines.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells	Cytotoxic T lymphocyte (CTL) precursor frequency	One year