Clinical Trials Results
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This phase II/III trial studies how well radiation therapy works when given together with
cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with
high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous
cell). Specialized radiation therapy that delivers a high dose of radiation directly to the
tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in
chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a
monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. The purpose of this study is to compare the usual treatment (radiation therapy with
cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy,
and using the usual treatment plus an immunotherapy drug, atezolizumab.
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This phase II trial studies how well the addition of olaparib to the usual treatment,
temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or
paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed
by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP
inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair
themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide, work
in different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving olaparib with temozolomide may
shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than
temozolomide alone.
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This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual
treatment (everolimus) in treating patients with somatostatin receptor positive bronchial
neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive
drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may
reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus
in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
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This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following
definitive treatment with radiation and chemotherapy (cisplatin) result in significant
improvement in overall survival (time being alive) and progression-free survival (time being
alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive
oropharynx cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy
such as cisplatin work in different ways to stop the growth of tumor cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. Radiation
therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with
monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet
known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy
works better than chemotherapy and radiation therapy alone in treating patients with HPV
positive oropharyngeal cancer.
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This randomized phase II trial studies how well chemotherapy before surgery and radiation
therapy works compared to surgery and radiation therapy alone in treating patients with nasal
and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such
as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.
Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and
reduce the amount of normal tissue that needs to be removed and treated with radiation.
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This phase II trial studies the effect of pembrolizumab in combination with radiation therapy
or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy)
after surgery in treating patients with head and neck squamous cell carcinoma that has come
back (recurrent). Radiation therapy uses high energy radiation or protons to kill tumor cells
and shrink tumors. Chemotherapy drugs, such as cisplatin and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such
as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with
the ability of tumor cells to grow and spread. Giving pembrolizumab in combination with
radiation therapy or pembrolizumab alone after surgery may work better than the usual
approach in shrinking head and neck squamous cell carcinoma.
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This phase II/III compares the standard chemotherapy alone to adding bevacizumab to standard
chemotherapy, or a combination of just bevacizumab and atezolizumab in treating patients with
head and neck cancers that have spread to other places in the body (advanced stage).
Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. Bevacizumab and cetuximab are monoclonal antibodies that may interfere with the
ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin,
carboplatin, and docetaxel, work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading. The
addition of bevacizumab and/or atezolizumab could shrink or stabilize head and neck cancers
or stop them from growing.
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There are two study questions we are asking in this randomized phase II/III trial based on a
blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally
advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard
concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if
there is no detectable EBV DNA in their plasma, then patients are randomized to either
standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still
detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and
fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high
energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,
fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil
is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in
treating patients with nasopharyngeal cancer.
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This phase II/III trial studies how well a reduced dose of radiation therapy works with
nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive
oropharyngeal cancer that is early in its growth and may not have spread to other parts of
the body (early-stage), and is not associated with smoking. Radiation therapy uses
high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as
cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with
monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is
being done to see if a reduced dose of radiation therapy and nivolumab works as well as
standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.
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This phase II/III trial studies how well sentinel lymph node biopsy works and compares
sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for
early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that
removes a smaller number of lymph nodes from your neck because it uses an imaging agent to
see which lymph nodes are most likely to have cancer. Standard neck dissection, such as
elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph
node biopsy surgery may work better in treating patients with early-stage oral cavity cancer
compared to standard elective neck dissection.
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This phase II/III trial compares the effect of the combination of high-dose cisplatin every
three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for
the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy
drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study
is being done to find out if low-dose cisplatin given weekly together with radiation therapy
is the same or better than high-dose cisplatin given every 3 weeks together with radiation
therapy in treating patients with head and neck cancer.
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This phase II trial tests whether ado-trastuzumab emtansine works to shrink tumors in
patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to
other places in the body (metastatic), or cannot be removed by surgery (unresectable).
Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy
drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way
and delivers emtansine to kill them. Trastuzumab emtansine may work better compared to usual
treatment of chemotherapy with docetaxel and trastuzumab in treating patients with salivary
gland cancer.
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This phase II trial studies the good and bad effects of the combination of drugs called
cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck
cancer that has spread to other places in the body (advanced). Cabozantinib may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy
with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may
help doctors determine how quickly patients can be divided into groups based on biomarkers in
their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or
in tissues that is a sign of a normal or abnormal process or a sign of a condition or
disease. A biomarker may be used to see how well the body responds to a treatment for a
disease or condition. The two biomarkers that this trial is studying are "tumor mutational
burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors
learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients
respond differently to the combination depending on the status of the biomarkers.
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