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Improved Therapy Response Assessment in Metastatic Brain Tumors (TREATMENT)

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ClinicalTrials.gov Identifier: NCT03458455
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Hospital of Southern Norway Trust
Ostfold Hospital Trust
St. Olavs Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
University Medical Center Groningen
University of Texas Southwestern Medical Center
South-Eastern Norway Regional Health Authority
Norwegian Cancer Society
Information provided by (Responsible Party):
Kyrre Eeg Emblem, Oslo University Hospital

Brief Summary:

TREATMENT is an observational study addressing the need for knowledge and adequate diagnostic biomarkers in the response assessment of patients with brain metastasis. Reliable response assessment will be highly relevant in the coming years given the introduction of next-generation cancer drugs, including immunotherapy. This project uses advanced Magnetic Resonance Imaging (MRI) and Vessel Architecture Imaging (VAI) to better understand the response to traditional stereotactic radiosurgery (SRS) and immunotherapy.

Secondary objectives include:

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to reveal parameters of traditional, immunotherapeutic, and anti-angiogenic therapy response.

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to compare results with traditional biomarkers.

Use existing infrastructure at Oslo University Hospital to standardize therapy monitoring.

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to separate real tumor progression from treatment-induced pseudoprogression or radionecrosis

In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods to assess whether anti-angiogenic drugs improve delivery of chemotherapy.


Condition or disease Intervention/treatment
Brain Metastases Diagnostic Test: Magnetic Resonance Imaging Radiation: Stereotactic Radiosurgery Drug: Ipilimumab, nivolumab or pembrolizumab

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Improved Therapy Response Assessment in Metastatic Brain Tumors
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions
Diagnostic Test: Magnetic Resonance Imaging
Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.
Other Name: Vessel Architectural Imaging

Radiation: Stereotactic Radiosurgery
A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.

B
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions
Diagnostic Test: Magnetic Resonance Imaging
Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.
Other Name: Vessel Architectural Imaging

Radiation: Stereotactic Radiosurgery
A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.

C
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + nivolumab or pembrolizumab
Diagnostic Test: Magnetic Resonance Imaging
Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.
Other Name: Vessel Architectural Imaging

Radiation: Stereotactic Radiosurgery
A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.

Drug: Ipilimumab, nivolumab or pembrolizumab
A type of therapy that uses substances to stimulate the immune system to help the body fight cancer by blocking inhibitory receptors on lymphocytes to overcome immune tolerance.
Other Name: Immunotherapy

D
Patients with brain metastases from malignant melanoma receiving stereotactic radiosurgery to selected lesions + ipilimumab, nivolumab or pembrolizumab
Diagnostic Test: Magnetic Resonance Imaging
Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.
Other Name: Vessel Architectural Imaging

Radiation: Stereotactic Radiosurgery
A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.

Drug: Ipilimumab, nivolumab or pembrolizumab
A type of therapy that uses substances to stimulate the immune system to help the body fight cancer by blocking inhibitory receptors on lymphocytes to overcome immune tolerance.
Other Name: Immunotherapy

E
Patients with brain metastases from non-small cell lung cancer receiving stereotactic radiosurgery to selected lesions + epidermal growth factor receptor (EGFR) inhibitors
Diagnostic Test: Magnetic Resonance Imaging
Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.
Other Name: Vessel Architectural Imaging

Radiation: Stereotactic Radiosurgery
A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.




Primary Outcome Measures :
  1. Treatment Response [ Time Frame: 18 months ]
    Radionecrosis, pseudoprogression or tumor progression by Response Assessment in Neuro-Oncology Criteria (RANO) or histology, or radiographic/clinical progression free survival


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Overall survival



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
Sampling Method:   Probability Sample
Study Population

Both men and women of all races and ethnic groups are eligible for this trial.

Cohort A: Accrual of up to 55 patients with brain metastases from NSCLC may be required in order to achieve 50 evaluable patients.

Cohort B: Accrual of up to 33 patients with brain metastases from malignant melanomas may be required in order to achieve 30 evaluable patients.

Cohort C: Accrual of up to 55 patients with brain metastases from malignant melanomas may be required in order to achieve 50 evaluable patients.

Cohort D: Accrual of up to 33 patients with brain metastases from malignant melanomas may be required in order to achieve 30 evaluable patients.

Cohort E: Accrual of up to 22 patients with brain metastases from malignant melanomas may be required in order to achieve 20 evaluable patients.

Criteria

Inclusion Criteria:

  • Participants must have histologically - or - radiographically confirmed metastatic disease from a primary non-small-cell lung cancer - or - metastatic melanoma.
  • Participants must have measurable disease in the central nervous system (CNS), defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI - or - compromise more than 30 image voxels on perfusion MRI to ensure adequate parametric statistical assessments. For a perfusion MRI resolution of 1.2x1.2x5mm, this equals a tumor volume of 0.2cubic centimeters (cc).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Karnofsky ≥60%)
  • Life expectancy of greater than 6 weeks
  • Eligible for stereotactic radiosurgery
  • Have normal organ functions per clinical guidelines
  • Ability to understand and the willingness to sign a written informed consent document.
  • Previously untreated asymptomatic brain metastases - or - progressive brain metastases after systemic therapy or prior local therapy such as radiation or surgery as defined by:

    1. Untreated measurable lesions in patients that have received surgery and/or SRS to one or more other lesions
    2. Residual or progressive lesions after surgery if asymptomatic
    3. Patients who have had prior whole-brain radiation therapy (WBRT) and/or SRS and then whose lesions have progressed are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression
    4. Progression after prior systemic therapy.

Exclusion Criteria:

  • Participants who received major surgery must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a diagnosis of immunodeficiency or hypersensitivity to ipilimumab or any of its excipients (Cohorts C and D).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has a known additional malignancy that is progressing or requires active treatment.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Unable to undergo brain MRI

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): NCT03458455


Contacts
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Contact: Kyrre E Emblem, PhD 97080018 ext 0047 Kyrre.Eeg.Emblem@rr-research.no
Contact: Endre Groevik, PhD 97525211 ext 0047 endre.grovik@mn.uio.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Anne Catrine T Martinsen, PhD    99216566 ext 0047    uxneti@ous-hf.no   
Contact: Atle Bjornerud, PhD    97539499 ext 0047    atle.bjornerud@fys.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Hospital of Southern Norway Trust
Ostfold Hospital Trust
St. Olavs Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
University Medical Center Groningen
University of Texas Southwestern Medical Center
South-Eastern Norway Regional Health Authority
Norwegian Cancer Society
Investigators
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Principal Investigator: Kyrre E Emblem, PhD Oslo University Hospital

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Kyrre Eeg Emblem, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03458455     History of Changes
Other Study ID Numbers: 2013/1033 LOOPS
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Within one year following study end, anonymized data will be uploaded to the appropriate online repositories to promote open access. This anonymized data includes general clinical information deemed non-identifiable (age, weight, gender, diagnosis and any prior treatments), imaging data (MRI with exam intervals only, no dates), corresponding results of any tissue analyses as well as study treatments (with treatment doses and intervals, no dates).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kyrre Eeg Emblem, Oslo University Hospital:
TREATMENT
Vessel Architectural Imaging
Brain Metastases

Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Pembrolizumab
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents