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

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. 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

Tracking Information
First Submitted Date  ICMJE August 15, 2018
First Posted Date  ICMJE August 20, 2018
Last Update Posted Date August 20, 2018
Estimated Study Start Date  ICMJE November 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • 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
  • 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
  • overall survival [ Time Frame: Through study completion, an average of 6 months ]
    Time to death for each subject, measured from time of enrollment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Metastases
  • Lung Cancer Metastatic
  • Breast Cancer Metastatic
Intervention  ICMJE Biological: DCVax-Direct
activated, autologous dendritic cells
Study Arms  ICMJE Experimental: Experimental Treatment
Intratumoral injection of activated, autologous dendritic cells (DCVax-Direct) in brain metastases from lung cancer or breast cancer
Intervention: Biological: DCVax-Direct
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03638765
Other Study ID Numbers  ICMJE 050811
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northwest Biotherapeutics
Study Sponsor  ICMJE Northwest Biotherapeutics
Collaborators  ICMJE Mayo Clinic
Investigators  ICMJE
Principal Investigator: Alfredo Quinones Hinojosa, MB Mayo Clinic
PRS Account Northwest Biotherapeutics
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP