Clinical trial NCT01635283: Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
Official title: A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Diffuse Astrocytoma
Adult Mixed Glioma
Adult Oligodendroglioma
Recurrent Adult Brain Tumor
Adult Oligoastrocytoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 5
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 primary purpose of this phase II clinical trial is to determine the safety and effect on survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a treatment for low-grade glioma patients. Other goals of this study are to determine if the vaccine can cause an immune response against patients' cancer cells and slow the growth of their brain tumors

Detailed description: PRIMARY OBJECTIVES:

I. To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.

SECONDARY OBJECTIVES:

I. To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.

OUTLINE:

Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol
* Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
* After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established
* Patients must be able to read and understand the informed consent document; patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
* Patients must have a Karnofsky performance status (KPS) rating of \>= 60 prior to initiating treatment; patients may be enrolled at a KPS of \< 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of \>= 60 by the initiation of treatment
* Hemoglobin \>= 9 gm%
* Absolute granulocyte count \>= 1,500
* Platelet count \>= 100,000/microliter (uL)
* Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times institutional normals
* Bilirubin =\< 1.5mg%
* Blood urea nitrogen (BUN) or creatinine =\< 1.5 times institutional normals

Exclusion Criteria:

* Subjects with an active infection
* Inability to obtain informed consent because of psychiatric or complicating medical problems
* Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
* Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
* History of immunodeficiency (e.g., human immunodeficiency virus \[HIV\]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy
* Subjects with organ allografts
* Inability or unwillingness to return for required visits and follow-up exams
* Subjects who have an uncontrolled systemic malignancy that is not in remission

Primary outcomes:
measure: Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
timeFrame: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
measure: Anti-tumor Immune Responses
timeFrame: Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Robert Prins
role: PRINCIPAL_INVESTIGATOR
References: