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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC/AAT | Drug | Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens. |
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| Measure | Description | Time Frame |
|---|---|---|
| Toxicity- assessment of safety and tolerability | week 0 to week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurable disease | baseline and after completion of vaccination | |
| Activity-monitoring both clinical and immunologic parameters | week 0 to week 9 |
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Inclusion 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
Recovered from toxicity of any prior therapy
Biologic Therapy
Chemotherapy:
Endocrine evaluation/therapy:
Radiotherapy:
Surgery:
Patient Characteristics
Age: 18 and over, able to give written informed consent. May be obtained through use of legal representation such as a health care proxy
Performance status: Karnofsky 60-100%
Life expectancy: at least 4-6 months
Hematopoietic:
Hepatic: bilirubin less than 2mg/dL OR SGOT less than 2x ULN
Renal: Creatinine no greater than 2mg/dL
Cardiovascular:
Pulmonary: No symptomatic pulmonary disease or pulse oximetry less than 93% on room air
Endocrine: No history of autoimmune thyroid disease
Radiographic: baseline contrast-enhanced MRI or CT scan of brain post surgical resection
Coagulation: No unexplained INR >2
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Darnell, MD, PhD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25475068 | Derived | 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. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| DC/AAT-Flu | Drug | Intradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT |
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| 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. |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |