alloCTL: Cellular Immunotherapy Study for Brain Cancer

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gliomas Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Mixed Glioma Glioblastoma Multiforme Malignant Meningioma	Drug: alloreactive CTL	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: alloreactive CTL arm	Drug: alloreactive CTL cellular immunotherapy with alloCTL

Arm

Intervention/Treatment

Experimental: alloreactive CTL arm

Drug: alloreactive CTL

cellular immunotherapy with alloCTL

Outcome Measures

Primary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability [5 years]

Secondary Outcome Measures

Maximum tolerated dose [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.