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Cellular Immunotherapy Study for Brain Cancer (alloCTL)

Primary Purpose

Gliomas, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

alloreactive CTL

About this trial

This is an interventional treatment trial for Gliomas focused on measuring Recurrent Grade III or Grade IV Gliomas, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, biotherapy, malignant meningioma

Eligibility Criteria

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

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.

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

alloreactive CTL arm

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Maximum tolerated dose

Full Information

NCT ID

NCT01144247

First Posted

June 11, 2010

Last Updated

May 26, 2016

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01144247

Brief Title

Cellular Immunotherapy Study for Brain Cancer

Acronym

alloCTL

Official Title

A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Recurrent Grade III or Grade IV Gliomas, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, biotherapy, malignant meningioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

alloreactive CTL arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

alloreactive CTL

Intervention Description

cellular immunotherapy with alloCTL

Primary Outcome Measure Information:

Title

Number of patients with adverse events as a measure of safety and tolerability

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Maximum tolerated dose

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20946667

Citation

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.

Results Reference

background

PubMed Identifier

22347526

Citation

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.

Results Reference

background

PubMed Identifier

9390198

Citation

Kruse CA, Cepeda L, Owens B, Johnson SD, Stears J, Lillehei KO. Treatment of recurrent glioma with intracavitary alloreactive cytotoxic T lymphocytes and interleukin-2. Cancer Immunol Immunother. 1997 Oct;45(2):77-87. doi: 10.1007/s002620050405.

Results Reference

result

Citation

Kruse, C.A., Rubinstein, D. (2001) Cytotoxic T Lymphocytes Reactive to Patient Major Histocompatibility Proteins for Therapy of Recurrent Primary Brain Tumors, in Brain Tumor Immunotherapy, eds. L.M. Liau, D.P. Becker, T.F. Cloughsey, and D. Bigner, Humana Press, pp. 149-170

Results Reference

result

Links:

URL

http://neurosurgery.ucla.edu/default.cfm

Description

Related Info

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Cellular Immunotherapy Study for Brain Cancer

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