Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
Olfactory NeuroblastomaEsthesioneuroblastoma1 moreBackground: Olfactory neuroblastoma (ONB) is a rare cancer of the nasal cavity. At diagnosis, it is usually locally advanced. It tends to spread to the neck. Sometimes it spreads to the lungs and bones. Researchers want to find a better way to treat it. Objective: To learn if giving immunotherapy drug bintrafusp alfa can help ONB shrink or disappear. Eligibility: People aged 18 years and older diagnosed with recurrent or metastatic ONB that has not responded to standard treatment. Design: Participants will be screened with a medical history, blood and urine tests, and physical exam. Their ability to perform their normal activities will be assessed. They will have an electrocardiogram to evaluate their heart. They will have imaging scans and/or a nuclear bone scan, as needed. For some scans, they may receive a contrast dye. Some screening tests will be repeated during the study. Participants will receive bintrafusp alfa once every 2 weeks for 26 doses. They will get it intravenously over 60 minutes. They may get other medicines to prevent side effects. They will complete health questionnaires. Visits will last 4-6 hours. Participants may have optional tumor biopsies. Participants will have an end of treatment visit within 7 days after they stop taking the study drug. About 28 days after treatment ends, they will have a safety visit. They will have follow-up visits every 3 months for the first year, then every 6 months for years 2-5, and then once a year after that for the rest of their life. If their disease progresses, they may be eligible for re-treatment with the study drug
Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy
Adenoid Cystic CarcinomaSquamous Cell Carcinoma7 moreThe purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rate and lowered toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result in equivalent or improved local control rate with similar or lower toxicity compared to IMRT, in the treatment of locally advanced sinonasal malignancy. Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in promising outcome in patients with sinonasal malignancy. To this date, no prospective study has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton radiation therapy. This Phase II trial is the first prospective study conducted to determine the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer. IMRT and proton radiation therapy are the two most established and most commonly employed advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly controversial whether one is superior to the other in terms of local control and toxicity outcome. It is also not clear if a subset of patients would benefit more from one treatment technology versus the other. Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam is only available at a few centers in the United States, it is not feasible at present to do a Phase III study randomizing patients between IMRT and proton radiation therapy. In this study, a planned secondary analysis will be performed, comparing the treatment and toxicity outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial will be used to design future multi-center prospective trials and to determine if randomized trial is necessary. In this study, the treatment technique employed for an individual case will not be determined by the treating physician(s), but rather by the most advanced technology available at the treating institution for the treatment of the sinonasal cancer. At the Massachusetts General Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility criteria. For institutions where protons are not available or institutions where the proton planning systems have not been optimized, IMRT exclusively will be used for the treatment of sinonasal cancer. Patient and tumor characteristics are expected to be comparable between IMRT- and proton- institutions
A Natural History Study of Children and Adults With Olfactory Neuroblastoma
Olfactory NeuroblastomaEsthesioneuroblastomaBackground: Olfactory neuroblastoma (ONB) is a rare cancer. It grows from tissue in the upper part of the nose cavity, related to the sense of smell and can affect a person s sense of smell. Researchers want to better understand the health problems of people with ONB. This may help them design better treatment and supportive care studies. Objective: To better understand ONB-the course of the disease, tumor characteristics, response to treatments, and management of the treatment. Eligibility: People ages 3 years and older who have ONB. They must enroll in NIH studies #19-C-0016 and #18-DC-0051. Design: Participants will be screened with a medical history and medical record review. Participants do not have to visit NIH. Participants will give a blood sample. They will complete surveys to assess their emotional and physical wellbeing and needs. Leftover tissue from biopsies and surgeries will be collected. Participants will take smell tests. They will smell items and answer questions about them. Participants may take taste tests. They will get plastic taste strips that they will move around their mouth to determine the taste. Participants may have a physical exam. Their performance status may be assessed. Participants may give blood, saliva, urine, and nasal secretion samples. Participants may have computed tomography and/or magnetic resonance imaging scans. Participants may have one or more tumor biopsies. Participants will talk to the research team about the results of their medical record/tests evaluation. The team will recommend how to best manage and treat their disease. Participants may give samples and complete surveys every 12 months. Their medical records will be reviewed every year. They will be monitored for the rest of their life.
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors....
CNS TumorsMeningioma5 moreThe study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain, such as small cell carcinoma of the lung. The study indication is to determine the diagnostic utility of 68Ga-DOTATATE PET/MRI in the diagnosis and management of patients with SSTR-positive CNS tumors, specifically whether 68Ga-DOTATATE PET/MRI demonstrates utility distinguishing between tumor recurrence and post-treatment change. To date, the utility of Ga-68-DOTATATE PET/MRI in meningioma has not been explored. Investigators have over the past 3 months been able to accrue the largest case series of presently 12 patients in whom Ga-68-DOTATATE PET/MRI demonstrated utility in the assessment of meningioma, including assessment for postsurgical/postradiation recurrence, detection of additional lesions not visualized on MRI alone, and evaluation of osseous invasion. Based on this initial experience, investigators intend to study the impact of Ga-68-DOTATATE PET/MRI in the assessment of the extent of residual tumor in patients status post meningioma resection, specifically in patients in whom tumor location limits resectability, patients with World Health Organization (WHO) grade II/III disease, and patients with history of stereotactic radiosurgery (SRS) who develop postradiation change.
Long-Term Longitudinal QoL in Patients Undergoing EEA
Pituitary TumorMeningioma6 moreThis is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.
Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent...
Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the Lip53 moreThis phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced...
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Adenoid Cystic Carcinoma of the Oral Cavity52 moreMonoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may be an effective treatment for head and neck cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy works in treating patients who have advanced head and neck cancer
Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors
Male Breast CancerRecurrent Adenoid Cystic Carcinoma of the Oral Cavity75 moreThis phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die.
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head...
Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the Lip47 moreThis phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer
Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer,...
Adenocarcinoma of the ColonAdenocarcinoma of the Rectum65 moreThis phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.