Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells Administered to Patients With Brain Tumors

Completed · Phase 1

Conditions studied: Brain Tumors

In brief

This study involves cancer research and the purpose is to assess the safety and activity of a type of vaccine as immune therapy for cancer. This vaccine will be made from each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify foreign material in the body (such as bacteria, viruses, or tumor cells). When DCs recognize this material, they use it to activate other cells of the immune system to mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology, each participant's DCs will be loaded with samples of their own tumor cells that were obtained at surgical resection. These tumor cells are killed in the laboratory using a special protocol, and then "fed" to the DCs. The DCs "eat" this material, and these "fed" DCs make up the vaccine.

Key facts

Study ID

NCT00893945

Run by

Rockefeller University

People needed

19

Starts

2007-06-01

Expected to finish

2013-12-01

Last updated by the study team

2014-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Screening to determine eligibility (with the exception of HLA haplotyping) will be completed within 45 days fo study entry.
• Disease Characteristics
• Histologically confirmed brain cancers, reviewed at MSKCC. Pathologic examination will be of surgical resection specimens deemed of suitable quality for definitive diagnosis by the histopathologist.
• Primary Brain Tumors:
• Anaplastic astrocytoma
• Glioblastoma multiforme
• Anaplastic oligodendroglioma
• Malignant mixed oligoastrocytoma
• Secondary (metastatic) brain tumors - newly diagnosed or recurrent disease
• All histological grade of disease accepted
• Surgically accessible tumor for which resection is indicated. Tumors may be from initial resections or re-resections. Recovery of a minimum of 1x10\^7 tumor cells ex vivo is required.
• Patients with primary brain tumors must have been previously treated with conventional therapy.
• Prior/Concurrent Therapy
• Recovered from toxicity of any prior therapy
• Biologic Therapy
• No concurrent other immunotherapy and no prior immunotherapy with any of the components of the current regimen (autologous DCs, cancer cells, or KLH)
• Chemotherapy:
• No concurrent immunomodulatory or chemotherapy therapy
• Chemotherapy, including temozolomide and local chemotherapies such as Gliadel Wafers, must be deferred until after last post-vaccine leukapheresis
• Endocrine evaluation/therapy:
• steroid dose no greater than 1mg daily dexamethasone (or equivalent)
• Radiotherapy:
• No concurrent brain radiation
• Surgery:
• Surgical resection must have been completed independently of this study, and suitable samples obtained for vaccine production

You may not qualify if…

• No active infection requiring antibiotics
• No history of HIV, hepatitis B or hepatitis C virus infection, no history of high risk behavior for such infection (intravenous drug abuse, men having unprotected sex with men). Laboratory evaluation for HIV, hepatitis B, hepatitis C to be obtained prior to study entry
• No history of hypersensitivity to vaccine components
• No history of autoimmune or vasculitic disease (including but not limited to systemic lupus erythematosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis, Wegener's granulomatosis), scleroderma, multiple sclerosis, juvenile-onset insulin-dependent diabetes
• No medical or psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements
• No alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements

Where it is running

• Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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