Cellular Immunotherapy Study for Brain Cancer | NCT01144247

Studies
Cellular Immunotherapy Study for Brain Cancer

NCT01144247

Sponsor

Jonsson Comprehensive Cancer Center

Status

Completed

Last Update Posted

May 27, 2016Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Gliomas
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Mixed Glioma
Glioblastoma Multiforme
Malignant Meningioma

Interventions

alloreactive CTL

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

ID	Type	Description	Link
R01CA125244	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

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

Jul 2010

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jun 11, 2010

First Submission Date that Met QC Criteria

Jun 14, 2010

First Posted Date

Jun 15, 2010Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2016

Last Update Posted Date

May 27, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH

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

The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
alloreactive CTL arm	Experimental		Drug: alloreactive CTL

Name	Type	Description	Arm Group Labels	Other Names
alloreactive CTL	Drug	cellular immunotherapy with alloCTL	alloreactive CTL arm

Measure	Description	Time Frame
Number of patients with adverse events as a measure of safety and tolerability		5 years

Measure	Description	Time Frame
Maximum tolerated dose		3 years

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

To participate in this clinical trial, patients must meet the following eligibility criteria:

Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI.
Tumor must be amenable to resection, and surgical resection must be clinically indicated.
Age at least 18 years.
Karnofsky performance scale score >60.
Adequate hematologic function: a) systemic white blood cell count greater than 2 x 103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%.
Adequate renal function, with creatinine less than two times the upper limit.
Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin < 2x upper limit of normal.
Patients must have an expected survival of at least three months.
Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.
Patients must sign an informed consent.

EXCLUSION CRITERIA

Patients will be excluded from the trial if the patients:

have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.
have prior tumor resections where the ventricles were extensively breached.
are pregnant or breast-feeding women.
are females of child-bearing potential unable or unwilling to practice adequate birth control methods.
have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
have concurrent systemic infection.
have any clinically significant, uncontrolled medical illness, as determined by the investigators.
are unwilling or unable to comply with procedures required in this protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Los Angeles		Los Angeles	California	90095	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20946667	Background	Hickey MJ, Malone CC, Erickson KL, Jadus MR, Prins RM, Liau LM, Kruse CA. Cellular and vaccine therapeutic approaches for gliomas. J Transl Med. 2010 Oct 14;8:100. doi: 10.1186/1479-5876-8-100.
22347526	Background	Hickey MJ, Malone CC, Erickson KE, Gomez GG, Young EL, Liau LM, Prins RM, Kruse CA. Implementing preclinical study findings to protocol design: translational studies with alloreactive CTL for gliomas. Am J Transl Res. 2012;4(1):114-26. Epub 2012 Jan 10.

ID	Term
D005910	Glioma
D001254	Astrocytoma
D009837	Oligodendroglioma
D005909	Glioblastoma
D008579	Meningioma
D008224	Lymphoma, Follicular

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type