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Sponsors and Collaborators: |
Rockefeller University Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT00893945 |
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.
Condition | Intervention | Phase |
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Brain Tumors |
Drug: DC/AAT Drug: DC/AAT-Flu Drug: DC/KLH |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients With Brain Tumors |
Estimated Enrollment: | 16 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DC/ATT vaccine: Experimental
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor specimens.
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Drug: DC/AAT
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.
Drug: DC/AAT-Flu
Autologous dendritic cells which have been co-cultured with AAT that has been infected with temperature sensitive influenza virus ("FluMist") prior to induction of apoptotic death.
Drug: DC/KLH
Autologous dendritic cells which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control.
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If you are eligible, and you decide to join this research study, you will get two to three shots of the experimental vaccine, each three weeks apart.
You will then have a follow up period where we will monitor you and your medical records for any affects of the experimental treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion/ Exclusion Criteria:
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:
Secondary (metastatic) brain tumors - newly diagnosed or recurrent disease
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
Biologic Therapy
Chemotherapy:
Endocrine evaluation/therapy:
Radiotherapy:
Surgery:
Patient Characteristics
Hematopoietic:
Cardiovascular:
Other:
Gender and Minority Inclusion
Significant amounts of white blood cells are required from patient leukapheresates to generate this vaccine, and these are most readily obtained from patients with approximately an adult-size blood volume. Therefore, this study will be open to eligible individuals age 18 and older.
Contact: Robert Darnell, MD, PhD | (212) 327-7474 | darnelr@rockefeller.edu |
United States, New York | |
Rockefeller University | Recruiting |
New York, New York, United States, 10065 | |
Contact: Robert Darnell, MD, PhD 212-327-7474 darnelr@rockefeller.edu | |
Sub-Investigator: Lisa DeAngelis, MD | |
Sub-Investigator: Jerome Posner, MD | |
Sub-Investigator: Philip Gutin, MD | |
Sub-Investigator: Eric Holland, MD, PhD | |
Sub-Investigator: Mayu Frank, MS, ANP | |
Sub-Investigator: Noreen Buckley, MS, APRN, BC | |
Sub-Investigator: Julia Kaufman, PhD | |
Sub-Investigator: Salina Parveen, MS | |
Sub-Investigator: Prerna Chopra, MS |
Principal Investigator: | Robert Darnell, MD, PhD | Rockefeller University |
Responsible Party: | Rockefeller University Hospital ( Robert Darnell, MD, PhD ) |
Study ID Numbers: | RDA-0611 |
Study First Received: | December 5, 2008 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00893945 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |