Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Pati... | NCT00576537

Studies
Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

NCT00576537

Sponsor

Cedars-Sinai Medical Center

Status

Completed

Last Update Posted

May 3, 2019Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Glioblastoma

Interventions

Dendritic Cell Immunotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 18, 2007

First Posted Date

Dec 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Oct 24, 2018

Certification/Extension First Submitted that Passed QC Review

Apr 30, 2019

Certification/Extension First Posted Date

May 3, 2019Actual

Last Update Submitted Date

Apr 30, 2019

Last Update Posted Date

May 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dendritic Cell Immunotherapy	Experimental	Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.	Biological: Dendritic Cell Immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dendritic Cell Immunotherapy	Biological	Patients will receive four vaccines.	Dendritic Cell Immunotherapy

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Yu, M.D.	Cedars-Sinai Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical center		Los Angeles	California	90048	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24893855	Derived	Jouanneau E, Black KL, Veiga L, Cordner R, Goverdhana S, Zhai Y, Zhang XX, Panwar A, Mardiros A, Wang H, Gragg A, Zandian M, Irvin DK, Wheeler CJ. Intrinsically de-sialylated CD103(+) CD8 T cells mediate beneficial anti-glioma immune responses. Cancer Immunol Immunother. 2014 Sep;63(9):911-24. doi: 10.1007/s00262-014-1559-2. Epub 2014 Jun 4.

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors