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1

Gamma <span class="highlight">Tile</span> Surgically Targeted Radiation Therapy after Brain Surgery for Brain Metastasis

A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma <span class="highlight">Tile</span> for Treatment of Newly Diagnosed Metastatic Brain Tumors.

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of Gamma <span class="highlight">Tile</span> Surgically Targeted Radiation Therapy (STaRT) and stereotactic radiation after brain surgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have 1-4 brain tumors that have not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove tumor and implant Gamma <span class="highlight">Tile</span> device</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gamma <span class="highlight">Tile</span> Surgically Targeted Radiation Therapy (STaRT)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove tumor</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gamma <span class="highlight">Tile</span> Surgically Targeted Radiation Therapy (STaRT) is a FDA-cleared radiation therapy.</li> <li class="seamTextUnorderedListItem">Gamma <span class="highlight">Tile</span> is a device implanted during surgery that delivers radiation directly to the tumor, called Surgically Targeted Radiation Therapy (STaRT).</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Additional brain tumors not removed during surgery will be treated with stereotactic radiation alone, which is standard of care.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04365374' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
1

Gamma <span class="highlight">Tile</span> Surgically Targeted Radiation Therapy after Brain Surgery for Brain Metastasis

A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma <span class="highlight">Tile</span> for Treatment of Newly Diagnosed Metastatic Brain Tumors.
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Nearest Location:
342 miles
Cedars-Sinai Medical Center
Los Angeles, CA

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT04365374

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Phase III

2

TBio-4101 <span class="highlight">TIL</span> Therapy with Pembrolizumab Immunotherapy for Advanced Breast Cancer

A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of TBio-4101, an experimental tumor infiltrating lymphocyte <span class="highlight">(TIL)</span> therapy, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received standard treatment. View full eligibility criteria

What's involved?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101</li> <li class="seamTextUnorderedListItem">IL-2</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 3 weeks for 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101 is an experimental immunotherapy called tumor infiltrating lymphocyte <span class="highlight">(TIL)</span> therapy.</li> <li class="seamTextUnorderedListItem">TBio-4101 is made by collecting, growing, and modifying specialized immune cells that are collected from your tumor. The immune cells may recognize, target, and kill the tumor cells.</li> <li class="seamTextUnorderedListItem">Before you receive the immune cells, you will be treated with the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). This is to prepare your body to receive the enhanced immune cells.</li> <li class="seamTextUnorderedListItem">IL-2 is a type of immunotherapy that activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05576077' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://turnstonebio.com/#our-science' target='_blank'>Turnstone Biologics: TBio-4101 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-targeted-therapies' target='_blank'>Breastcancer.org: Tumor Infiltrating Lymphocyte (TIL) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
2

TBio-4101 <span class="highlight">TIL</span> Therapy with Pembrolizumab Immunotherapy for Advanced Breast Cancer

A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)
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Nearest Location:
376 miles
University of California Irvine
Irvine, CA

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Visits:
May require hospitalization; 1 visit every 3 weeks for 2 years

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ClinicalTrials.gov: NCT05576077

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Phase I

3

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

Purpose: To study a new type of immunotherapy in which researchers take <span class="highlight">TILs</span> from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient.

Who is this for?: People with metastatic (stage IV) breast cancer and have a tumor that can be surgically removed. View full eligibility criteria

What's involved?

<p class="seamTextPara"> All participants will undergo the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor sample used to grow the tumor infiltrating lymphocyte</li> <li class="seamTextUnorderedListItem">White blood cells-depleting preparative regimen</li> <li class="seamTextUnorderedListItem">Followed by tumor Infiltrating Lymphocytes, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor infiltrating lymphocytes <span class="highlight">(TILs)</span> are the white blood cells that are found in tumors. </li> <li class="seamTextUnorderedListItem">The immune system has activated these cells to try to control the cancer's growth. </li> <li class="seamTextUnorderedListItem">This study is investigating a new type of immunotherapy in which researchers take <span class="highlight">TILs</span> from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient. </li> <li class="seamTextUnorderedListItem">Previous studies using <span class="highlight">TIL</span> in melanoma have shown effectiveness in shrinking the tumor. </li> <li class="seamTextUnorderedListItem">In this study, researchers will study the effectiveness of <span class="highlight">TIL</span> in shrinking breast (and other) tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01174121' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT01174121' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.esmo.org/Conferences/Past-Conferences/ESMO-2014-Congress/News-Articles/The-Promise-of-Tumour-Infiltrating-Lymphocytes-for-Cancer-Treatment-and-as-Prognostic-Predictive-Indicators' target='_blank'>ESMO: Tumor Infiltrating Lymphocytes in Melanoma</a> </li></ul>
3

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Hospital stay for about 4 weeks

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ClinicalTrials.gov: NCT01174121

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Phase II

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