Cellular Immunotherapy Study for Brain Cancer

NCT01144247 | Completed Phase 1 DMC

• 2 other identifiers: UCLA 07-09-008R01CA125244
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (1)

• Maximum tolerated dose

  3 years

Study Arms (1)

alloreactive CTL arm

EXPERIMENTAL

Drug: alloreactive CTL

Interventions

alloreactive CTL DRUG

cellular immunotherapy with alloCTL

alloreactive CTL arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (4)

• 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.

  PMID: 20946667 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.

  PMID: 22347526 BACKGROUND

• 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.

  PMID: 9390198 RESULT

• 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

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Glioblastoma; Meningioma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 15, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

US (1)