Brain MetastasesPhase 1NCT03638765
Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
A Phase 1 study testing DCVax-Direct in people with Brain Metastases and Lung Cancer Metastatic, run by Northwest Biotherapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases, Lung Cancer Metastatic, Breast Cancer Metastatic
- What is being tested?
- DCVax-Direct
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2018to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent
- Age between 18 and 75 years (inclusive) at screening.
- Willingness to provide Social Security Number to facilitate survival follow up.
- Pathologically confirmed metastatic breast or non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Adequate bone marrow function, as indicated by the following:
Show all 14Show fewer
- Adequate renal function
- Adequate liver function
- Life expectancy > 12 weeks
- Negative serum pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
- 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.
- 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
- At least one CNS metastasis accessible for reservoir placement
- At least one measurable CNS metastasis (lesion ≥ 10 mm per RANO-BM criteria)
Who cannot join
- 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
- Immunocompromised patients and patients with known immunodeficiency
- 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.
- 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).
- 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.
- Known history of, or any evidence of active, non-infectious pneumonitis.
Show all 23Show fewer
- Active infection requiring systemic therapy.
- 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.
- 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.
- 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.
- Stage IV lung cancer patients with actionable EGFR, ALK or ROS-1 alteration will be excluded from the study.
- Serious medical conditions
- Any systemic myelotoxic chemotherapy within 8 weeks prior to screening
- Evidence of recent hemorrhage on MR at pre-screening
- Positive HIV-1, HIV-2, or HTLV-I/II tests.
- History of multiple sclerosis
- Requirement for ongoing immunosuppressants
- Ongoing medical need for continuous anti-coagulation or anti-platelet medication,
- Known genetic cancer-susceptibility syndromes such as Li-Fraumeni syndrome
- Ongoing fever for longer than 48 hours of ≥ 101.5oF/38.6oC at screening
- Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception.
- Allergy or anaphylaxis to any of the reagents used in this study
- Inability or unwillingness to return for required visits and follow-up exams
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic
Jacksonville, Florida, 32224
Alfredo Quinones Hinojosa, MD, 904-956-3435, Quinones-Hinojosa.Alfredo@mayo.edu
Ronald Reimer, MD, 904-783-6591
About this study
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
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.
- Being tested
- DCVax-Direct
- Keywords
- immunotherapy, dendritic cells, brain metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVax-DirectBiological
activated, autologous dendritic cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Intratumoral injection of activated, autologous dendritic cells (DCVax-Direct) in brain metastases from lung cancer or breast cancer Receives: Biological: DCVax-Direct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety is assessed graded according to NCI CTC. The overall incidence of adverse events is calculated.
Toxicity is monitored and graded according to NCI CTC. The overall incidence of adverse events is calculated
Measured: Through study completion, an average of 6 months
Secondary outcomes (3)
tumor response
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
Measured: Every 8 weeks through study completion, an average of 6 months
intracranial recurrence rate
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
Measured: Every 8 weeks through study completion, an average of 6 months
overall survival
Time to death for each subject, measured from time of enrollment
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study startNov 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwest Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Alfredo Quinones Hinojosa, MB, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638765
- Sponsor's protocol ID
- 050811
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03638765
- Acronym / sponsor ID
- 050811
- Keywords
- immunotherapy, dendritic cells, brain metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Northwest BiotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Nov 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Biological: DCVax-DirectIntratumoral injection of activated, autologous dendritic cells (DCVax-Direct) in brain metastases from lung cancer or breast cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide informed consent
- Age between 18 and 75 years (inclusive) at screening.
- Willingness to provide Social Security Number to facilitate survival follow up.
- Pathologically confirmed metastatic breast or non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
Key exclusion criteria (23 listed)
- 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
- Immunocompromised patients and patients with known immunodeficiency
- 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.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCVax-Directactivated, autologous dendritic cells | Biological | Experimental Treatment |
Primary outcome
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
3 secondary outcomes
tumor response
Time frame: Every 8 weeks through study completion, an average of 6 months
intracranial recurrence rate
Time frame: Every 8 weeks through study completion, an average of 6 months
overall survival
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Brain Metastases
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Quinones Hinojosa, MB principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DCVax-Direct in people with Brain Metastases and Lung Cancer Metastatic, run by Northwest Biotherapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marnix L Bosch, PhD (2404979022, marnix@nwbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.