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

This study has been completed.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00893945
First received: December 5, 2008
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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
Brain Tumors
Drug: DC/AAT
Drug: DC/AAT-Flu
Drug: DC/KLH
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Toxicity- assessment of safety and tolerability [ Time Frame: week 0 to week 9 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurable disease [ Time Frame: baseline and after completion of vaccination ] [ Designated as safety issue: No ]
  • Activity-monitoring both clinical and immunologic parameters [ Time Frame: week 0 to week 9 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: June 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DC/ATT vaccine
Autologous dendritic cells 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion/ Exclusion 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
    12. Other:

      • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893945

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Robert Darnell, MD, PhD Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00893945     History of Changes
Other Study ID Numbers: RDA-0611
Study First Received: December 5, 2008
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014