Clinical trial NCT01144247: Cellular Immunotherapy Study for Brain Cancer
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2010-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 5 years
Secondary outcomes:
measure: Maximum tolerated dose
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
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.
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.
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.
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