Cellular Immunotherapy Study for Brain Cancer

Glioblastoma Multiforme Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144247
• Other study ID #: UCLA 07-09-008
• Secondary ID: R01CA125244
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2010
• Last updated: May 26, 2016
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

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

1. 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.

2. Tumor must be amenable to resection, and surgical resection must be clinically indicated.

3. Age at least 18 years.

4. Karnofsky performance scale score >60.

5. 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%.

6. Adequate renal function, with creatinine less than two times the upper limit.

7. Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin < 2x upper limit of normal.

8. Patients must have an expected survival of at least three months.

9. Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.

10. Patients must sign an informed consent.

EXCLUSION CRITERIA

Patients will be excluded from the trial if the patients:

1. have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.

2. have prior tumor resections where the ventricles were extensively breached.

3. are pregnant or breast-feeding women.

4. are females of child-bearing potential unable or unwilling to practice adequate birth control methods.

5. have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).

6. have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.

7. have concurrent systemic infection.

8. have any clinically significant, uncontrolled medical illness, as determined by the investigators.

9. are unwilling or unable to comply with procedures required in this protocol.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• alloreactive CTL
cellular immunotherapy with alloCTL

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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, Human

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events as a measure of safety and tolerability		5 years	Yes
Secondary	Maximum tolerated dose		3 years	Yes

External Links

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