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

NCT00893945 | Completed Phase 1 DMC

• 1 other identifier: RDA-0611
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumors

Outcome Measures

Primary Outcomes (1)

• Toxicity- assessment of safety and tolerability

  week 0 to week 9

Secondary Outcomes (2)

• Measurable disease

  baseline and after completion of vaccination

• Activity-monitoring both clinical and immunologic parameters

  week 0 to week 9

Study Arms (1)

DC/AAT vaccine

EXPERIMENTAL

Intradermal injection of 3 Autologous dendritic cell vaccines (DC/AAT, DC/AAT-flu, DC/KLH) that have been co-cultured with autologous apoptotic tumor specimens.

Drug: DC/AAT; Drug: DC/AAT-Flu; Drug: DC/KLH

Interventions

DC/AAT DRUG

Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.

Also known as: Dendritic cell/autologous apoptotic tumor

DC/AAT vaccine

DC/AAT-Flu DRUG

Intradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT

Also known as: dendritic cell/flu-infected autologous apoptotic tumor

DC/AAT vaccine

DC/KLH DRUG

Intradermal injection of Autologous dendritic cell vaccine (DC/KLH) which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control.

Also known as: dendritic cell/Keyhole Limplet hemocyanin

DC/AAT vaccine

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Rockefeller University: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.

  PMID: 25475068 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Robert Darnell, MD, PhD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: May 6, 2009
• Study Start: June 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)