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Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer

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ClinicalTrials.gov Identifier: NCT03638765
Recruitment Status : Unknown
Verified August 2018 by Northwest Biotherapeutics.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Mayo Clinic
Information provided by (Responsible Party):
Northwest Biotherapeutics

Brief Summary:
The study will use an Ommaya reservoir that drains into brain metastases to deliver activated, autolous dendritic cells to the tumor lesion, for patients who are 18 - 75 years old who have brain metastases from either lung cancer or breast cancer. The primary objective of the study is to evaluate the safety and feasibility of administering DCVax-Direct to patients with metastatic tumors in the brain. The secondary objectives are to determine tumor response, the rate of intracranial recurrence (IR), the rate of neurologic deaths, decline in neuro-cognitive functioning and overall survival. Approximately 10 patients with injectable metastatic brain tumors will be enrolled initially in a dose escalation scheme, with the expectation to enroll a total of 24 patients.

Condition or disease Intervention/treatment Phase
Brain Metastases Lung Cancer Metastatic Breast Cancer Metastatic Biological: DCVax-Direct Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Clinical Trial Evaluating DCVax-Direct, Autologous Activated Dendritic Cells for Intratumoral Injection, in Patients With Unresectable Brain Metastases From Breast- or Non-Small Cell Lung Cancer
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Experimental Treatment
Intratumoral injection of activated, autologous dendritic cells (DCVax-Direct) in brain metastases from lung cancer or breast cancer
Biological: DCVax-Direct
activated, autologous dendritic cells

Primary Outcome Measures :
  1. Safety is assessed graded according to NCI CTC. The overall incidence of adverse events is calculated. [ Time Frame: Through study completion, an average of 6 months ]
    Toxicity is monitored and graded according to NCI CTC. The overall incidence of adverse events is calculated

Secondary Outcome Measures :
  1. tumor response [ Time Frame: Every 8 weeks through study completion, an average of 6 months ]
    Tumor response is assessed through radiographic means and must at a minimum include MRI scans with and without contrast. The newly proposed iRANO criteria are used to characterize responses

  2. intracranial recurrence rate [ Time Frame: Every 8 weeks through study completion, an average of 6 months ]
    Tumor recurrence in the brain is assessed through radiographic means and must at a minimum include MRI scans with and without contrast. The newly proposed iRANO criteria are used to characterize recurrences

  3. overall survival [ Time Frame: Through study completion, an average of 6 months ]
    Time to death for each subject, measured from time of enrollment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Willing and able to provide informed consent
  2. Age between 18 and 75 years (inclusive) at screening.
  3. Willingness to provide Social Security Number to facilitate survival follow up.
  4. Pathologically confirmed metastatic breast or non-small cell lung cancer
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  6. Adequate bone marrow function, as indicated by the following:
  7. Adequate renal function
  8. Adequate liver function
  9. Life expectancy > 12 weeks
  10. Negative serum pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  11. Determined prior to enrollment: sufficient number of doses of DCVax-Direct manufactured to complete 7 injections. A second leukapheresis is allowed to meet this requirement if necessary.
  12. Unequivocal evidence of newly diagnosed untreated brain metastases and/or progressive brain metastases after previous whole brain radiation therapy (WBRT), currently amenable to stereotactic radiosurgery
  13. At least one CNS metastasis accessible for reservoir placement
  14. At least one measurable CNS metastasis (lesion ≥ 10 mm per RANO-BM criteria)

Exclusion Criteria:

  1. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm OR Participated in a study of an investigational agent, received study therapy or used an investigational device ≤4 weeks prior to registration
  2. Immunocompromised patients and patients with known immunodeficiency
  3. Patients receiving systemic steroid therapy >10 mg prednisone or equivalent or any other immunosuppressive therapy ≤7 days prior to registration. NOTE: Inhaled steroids and low-dose corticosteroids are allowed.
  4. History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive) and/or active hepatitis C infection (e.g. HCV RNA qualitative is detected).
  5. Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents, corticosteroids or immunosuppressive drugs). NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  6. Known history of, or any evidence of active, non-infectious pneumonitis.
  7. Active infection requiring systemic therapy.
  8. Other active malignancy ≤3 years prior to registration. EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence ≤3 years prior to registration.
  9. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
  10. Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study.
  11. Stage IV lung cancer patients with actionable EGFR, ALK or ROS-1 alteration will be excluded from the study.
  12. Serious medical conditions
  13. Any systemic myelotoxic chemotherapy within 8 weeks prior to screening
  14. Evidence of recent hemorrhage on MR at pre-screening
  15. Positive HIV-1, HIV-2, or HTLV-I/II tests.
  16. History of multiple sclerosis
  17. Requirement for ongoing immunosuppressants
  18. Ongoing medical need for continuous anti-coagulation or anti-platelet medication,
  19. Known genetic cancer-susceptibility syndromes such as Li-Fraumeni syndrome
  20. Ongoing fever for longer than 48 hours of ≥ 101.5oF/38.6oC at screening
  21. Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception.
  22. Allergy or anaphylaxis to any of the reagents used in this study
  23. Inability or unwillingness to return for required visits and follow-up exams

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): NCT03638765

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Contact: Marnix L Bosch, PhD 2404979022 marnix@nwbio.com

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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Contact: Alfredo Quinones Hinojosa, MD    904-956-3435    Quinones-Hinojosa.Alfredo@mayo.edu   
Contact: Ronald Reimer, MD    904-783-6591      
Sub-Investigator: YanYan Lou, MD         
Sub-Investigator: Saranya Chumsri, MD         
Sub-Investigator: Kaisorn Chaichana, MD         
Sub-Investigator: Steven Rosenfeld, MD         
Sponsors and Collaborators
Northwest Biotherapeutics
Mayo Clinic
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Principal Investigator: Alfredo Quinones Hinojosa, MB Mayo Clinic
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Responsible Party: Northwest Biotherapeutics
ClinicalTrials.gov Identifier: NCT03638765    
Other Study ID Numbers: 050811
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northwest Biotherapeutics:
dendritic cells
brain metastases
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases