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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00893945
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : December 23, 2014
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Rockefeller University

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.

Condition or disease Intervention/treatment Phase
Brain Tumors Drug: DC/AAT Drug: DC/AAT-Flu Drug: DC/KLH Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : June 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: DC/AAT vaccine
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
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.
Other Name: Dendritic cell/autologous apoptotic tumor

Drug: DC/AAT-Flu
Intradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT
Other Name: dendritic cell/flu-infected autologous apoptotic tumor

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

Primary Outcome Measures :
  1. Toxicity- assessment of safety and tolerability [ Time Frame: week 0 to week 9 ]

Secondary Outcome Measures :
  1. Measurable disease [ Time Frame: baseline and after completion of vaccination ]
  2. Activity-monitoring both clinical and immunologic parameters [ Time Frame: week 0 to week 9 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Screening to determine eligibility (with the exception of HLA haplotyping) will be completed within 45 days fo study entry.

  1. 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.

  2. Prior/Concurrent Therapy

    1. Recovered from toxicity of any prior therapy
    2. 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)
    3. 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
    4. Endocrine evaluation/therapy:

      • steroid dose no greater than 1mg daily dexamethasone (or equivalent)
    5. Radiotherapy:

      • No concurrent brain radiation
    6. Surgery:

      • Surgical resection must have been completed independently of this study, and suitable samples obtained for vaccine production
  3. Patient Characteristics

    1. Age: 18 and over, able to give written informed consent. May be obtained through use of legal representation such as a health care proxy
    2. Performance status: Karnofsky 60-100%
    3. Life expectancy: at least 4-6 months
    4. Hematopoietic:

      • WBC greater than 3,800
      • Absolute lymphocytes greater than 500
      • Absolute neutrophil counter great than 1,500/mm^3
      • Platelets greater than 100,000/mm^3
      • Hb greater than or equal to 10g/dL
    5. Hepatic: bilirubin less than 2mg/dL OR SGOT less than 2x ULN
    6. Renal: Creatinine no greater than 2mg/dL
    7. Cardiovascular:

      • No NYHA class III/IV status
      • No active angina, uncontrolled clinically significant cardiac arrythmia, recent (6 months) myocardial infarction
    8. Pulmonary: No symptomatic pulmonary disease or pulse oximetry less than 93% on room air
    9. Endocrine: No history of autoimmune thyroid disease
    10. Radiographic: baseline contrast-enhanced MRI or CT scan of brain post surgical resection
    11. Coagulation: No unexplained INR >2

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893945

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United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Robert Darnell, MD, PhD Rockefeller University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00893945    
Other Study ID Numbers: RDA-0611
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases