Neoplasms

Gland and Hormone Related Diseases

All Conditions

Adrenal Gland Neoplasms

Adrenal Gland Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands

Endoscopic Ultrasound-Guided FNA

To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS.

A review of 205 EUS-FNA of AG in 200 patients is included.

INTRODUCTION: The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands.

OBJECTIVE: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG.

MATERIALS AND METHODS: National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.

EUS-guided FNA in the Study of the Adrenal Gland

EUS-guided FNA in the Study of the Adrenal Gland: National Retrospective Multicenter Study

Predictors of malignancy and cyto-pathological correlation of the EUS-FNA with adrenal gland

Hospital Universitari de Bellvitge

Principal Investigator

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Tumor and Marrow Markers

Nai-Kong Cheung, M.D., Ph.D.

Shakeel Modak, MD

The purpose of this study is to find out the genetic and biochemical makeup of your neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These research studies include surface marker analysis, cytogenetics, cancer genes,genome sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow, and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and your serum tested for anti-tumor antibodies.

To collect tumor, marrow specimens prospectively to study the molecular-genetic makeup of individual neuroblastic tumor and its metastasis by blood and marrow, and to correlate these findings with clinical outcome, and to relate the signaling circuitry of neuroblastic tumors to that of embryonic neuroectodermal cells. .

Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Before surgery a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient

Before surgery and a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient

Up to six fetal adrenal samples will be obtained (without patient identifiers) from gestational week 20, when neuroblasts are present and thought to be differentiating within the fetal adrenal gland.

Southern Illinois University

Spanish National Cancer Center

St. Jude Children's Research Hospital

Washington University School of Medicine

University of Texas

Weill Medical College of Cornell University

Memorial Sloan Kettering Cancer Center

Hormones

Patients who wll receive adrenal RF ablation.

Patients who will receive abdominal radiofrequency ablation other than adrenal gland.

Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group.

Radiofrequency ablation

Koichiro Yamakado, MD

The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.

Adrenal radiofrequency (RF) ablation has been increasingly used for the treatment of unresectable adrenal tumors. But one of the major complication is a increase in blood pressure. Hormonal release during RF ablation is considered the cause of hypertension. But there has been no evidence that adrenal hormones affects changes in blood pressure. In this prospective study, we evaluate the changes in adrenal hormones during RF ablation and clarify the cause of hypertensive crisis.

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.

Mie University

Clinical Professor

Patients who received adrenal radiofrequency (RF) ablation.

Adrenal Radiofrequency Ablation

Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.

Abdominal Radiofrequency Ablation Other Than Adrenal Gland

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Japan

Region of Enrollment

Small patient series is one of limitations of this study

Dr. Koichiro Yamakado

Increase in Catecholamine

Increase in Cortisol

Serum Cathecholamine Levels

Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation

Overall Study

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasm Metastasis

Lung Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Hematinics

Immunomodulating Agents

Ipilimumab

Liver Extracts

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants with at least 1 liver metastasis - Treatment Group 1: Ipilimumab 3 mg/kg by vein on Day 1 of all 21 day cycles for a total of 4 doses. SBRT 50 Gy in 4 fractions to 1 - 4 liver lesion(s) on Days 1 - 4 of Cycle 1.

Participants with at least 1 liver metastasis - Treatment Group 2: Ipilimumab 3 mg/kg by vein on Day 1 of Cycles 1 and 2. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 3 and 4. Each cycle is 21 days. SBRT 50 Gy in 4 fractions to 1 - 4 liver lesion(s) on Days 29 - 33 of each 21 day cycle.

Participants with at least 1 lung metastasis - Treatment Group 3: Ipilimumab 3 mg/kg by vein on Day 1 of all 21 day cycles for a total of 4 doses. SBRT 50 Gy in 4 fractions to 1 - 4 lung lesion(s) on Days 1 - 4 of Cycle 1.

Participants with at least 1 lung metastasis - Treatment Group 4: Ipilimumab 3 mg/kg by vein on Day 1 of Cycles 1 and 2. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 3 and 4. Each cycle is 21 days. SBRT 50 Gy in 4 fractions to 1 - 4 lung lesion(s) on Days 29 - 33 of each 21 day cycle.

Participants with 1 liver or lung metastasis - Treatment Group 5: Ipilimumab 3 mg/kg by vein on Day 1 of Cycle 1. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 2 - 4. Each cycle is 21 days. SBRT 60 Gy in 10 fractions to 1 - 4 lung, liver, or adrenal lesion (s) on Days 1 - 5 and Days 9 - 12 of Cycle 1.

Participants enrolled in this arm treated to a total dose of 50 Gy in 4 fractions, 60 Gy in 10 fractions, or 20 Gy in 5 fractions with stereotactic radiotherapy to a liver or lung lesion. The choice of radiation dose will be at the discretion of the treating radiation oncologist.

Participants receive Ipilimumab every 21 days for a total of 4 doses.

Treatment Group 1 and 3: Ipilimumab 3 mg/kg by vein on Day 1 of all 21 day cycles for a total of 4 doses.

Treatment Group 2 and 4: Ipilimumab 3 mg/kg by vein on Day 1 of Cycles 1 and 2. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 3 and 4.

Treatment Group 5: Ipilimumab 3 mg/kg by vein on Day 1 of Cycle 1. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 2-4

Treatment Group 1 and 3: SBRT 50 Gy in 4 fractions to 1 - 4 liver lesion(s) on Days 1 - 4 of Cycle 1.

Treatment Group 2 and 4: SBRT 50 Gy in 4 fractions to 1-4 liver lesion(s) on Days 29 - 33 of each 21 day cycle.

Treatment Group 5: SBRT 60 Gy in 10 fractions to 1 - 4 lung, liver, or adrenal lesion (s) on Days 1 - 5 and Days 9 - 12 of Cycle 1.

Stereotactic Body Radiation Therapy (SBRT)

James Welsh, MD

The goal of this clinical research study is to find the highest tolerable dose of ipilimumab and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these treatments given consecutively will also be studied.

This is an investigational study. SBRT is FDA approved for the control of metastatic and primary tumors. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma that cannot be removed with surgery. The use of SBRT with ipilimumab is investigational. The study doctor can explain how the study drug is designed to work.

Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

Participants on this study are enrolled into Phase 1 (Dose De-Escalation, or Dose-Finding) or Phase 2 (Dose Expansion), based on when they join the study.

Phase 1: Dose De-Escalation:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 5 groups based on the type of disease you have.

* If you are in Groups 1 or 3, you will receive SBRT and 1 dose of ipilimumab within a few days after your SBRT treatment, and then you will receive 3 more doses of ipilimumab.
* If you are in Groups 2, 4, or 5, you will receive 2 doses of ipilimumab, SBRT, and then 2 more doses of ipilimumab.

If you are in Group 5, SBRT will be given over a longer period of time (more days or weeks).

All participants will receive the same dose level of ipilimumab.

You will be given a separate consent form explaining SBRT and its risks.

In each group, 3 participants will be enrolled at the first dose level. If no more than 1 participant has intolerable side effects, up to 3 more participants will be enrolled at that dose level. If no intolerable side effects are seen at that dose level, that is considered the highest tolerated dose.

If enough intolerable side effects are seen at the assigned dose level, the total dose amount of radiation given in any group may be lowered up to 2 times.

Phase 2: Dose Expansion:

Once the highest tolerated dose combination is found in each study group, up to 14 more participants will be enrolled at that dose level combination in each group.

Study Drug Administration:

Each study cycle is 21 days.

If you are in Groups 1 or 3 (early ipilimumab and SBRT), you will receive ipilimumab by vein over about 90 minutes on Day 1 of all cycles. You will also receive SBRT over about 30-45 minutes on Days 1-4 of Cycle 1.

If you are in Groups 2 or 4 (late ipilimumab and SBRT), you will receive ipilimumab by vein over about 90 minutes on Day 1 of Cycles 1 and 2 and then SBRT on Days 29-33. After your SBRT treatment, you will take ipilimumab on Day 1 of Cycles 3 and 4.

If you are in Group 5 (late ipilimumab and SBRT), you will receive ipilimumab on Day 1 of Cycle 1 and SBRT over about 30-45 minutes on Days 1-5 and Days 9-12 of Cycle 1. After your SBRT treatment, you will take ipilimumab on Day 1 of Cycles 2-4.

You will be given standard drugs to help decrease the risk of side effects and to help support your immune system. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

During Week 1 of all cycles and Week 2 of Cycle 2:

* You will have a physical exam, including measurement of your weight.
* Blood (about 1 tablespoon) will be drawn for routine tests.

During Week 3 of Cycles 2 and 4, you will have an MRI, CT scan, and/or PET/CT scan to check the status of the disease.

If you are in Phase 2, during Week 3 of each cycle, blood (about 2 teaspoons) may be drawn for biomarker testing, if the doctor thinks it is safe.

You may have a chest scan if the doctor thinks it is needed.

Length of Study:

You may receive up to 4 cycles of treatment with ipilimumab and SBRT. About 8 weeks after you have completed Cycle 4, if the size of the tumor does not change or it gets smaller while you are receiving therapy, you may be able to continue to receive ipilimumab and/or radiation. The study doctor will discuss this option with you.

You will no longer be able to receive treatment if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after you have completed the follow-up visits.

Follow-Up:

About 30 days after your last dose of ipilimumab and then every 3 months after that for up to 2 years, you will come to the clinic for follow-up visits. At these visits:

* You will have a physical exam, including measurement of your weight..
* Blood (about 1 tablespoon) be drawn for routine tests.
* Blood (about 2 teaspoons) may be drawn for biomarker testing, if the doctor thinks it is safe.
* Urine will be collected for routine tests.
* You will have an MRI, CT scan, and/or PET/CT scan to check the status of the disease.

Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors

Phase I/II Trial of Ipilimumab (Immunotherapy) and Hypofractionated Stereotactic Radiation Therapy in Patients With Advanced Solid Malignancies

MTD defined as highest dose level with less than 2 patients with dose limiting toxicity (DLT) out of at least six patients in the cohort. All enrolled participants will be considered in the DLT analysis. If at any time more than or equal to one third (33%) of participants at a dose level experience DLT, the MTD will be reassessed and the next lowest dose level for the combination therapy considered the MTD.

Response and progression evaluated using guidelines proposed by the Immune Related Response Criteria (irRC). Patients with measurable disease also assessed using standard Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and World Health Organization (WHO) treatment response criteria. Complete Response (irCR): complete disappearance of all lesions (whether measurable or not, and no new lesions) confirmation by a repeat, consecutive imaging assessment no less than 4 wk from the date first documented. Partial Response (irPR): decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive imaging assessment at least 4 wk after first documentation. Progressive Disease (irPD): increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive imaging assessment no less than 4 wk from date first documented.

Bristol-Myers Squibb

M.D. Anderson Cancer Center

Syndrome

Cushing Syndrome

Cushing's Syndrome

Subjects with Hyperaldosteronism and cushing. Adults, pediatric subjects and family members (DNA collection only for family members).

Christina Tatsi, M.D.

The adrenal glands, located atop the kidneys, normally produce several types of hormones. Tumors of these glands may or may not secrete hormones. It is not known what causes these tumors or why some secrete hormones and others do not. Some of the tumors are benign and confined to the adrenal gland, and others are malignant (cancerous), and can spread to other parts of the body. This study will investigate how adrenal gland tumors develop, why some secrete steroid hormones and others do not, and why some are benign and others malignant.

Patients between 3 and 70 years old with a known or suspected adrenal gland tumor may be eligible for this study. Participants will be hospitalized for 7 to 10 days for various tests and procedures that may include the following:

1. Medical history and physical examination, including body measurements, as appropriate. Children and adolescents will have Tanner staging, including examination of the genitals, to determine the extent of sexual maturity.
2. 24-hour urine collection to measure hormones in the urine.
3. Imaging studies, including magnetic resonance imaging (MRI) of the brain, computed tomography (CT) and other X-ray studies.
4. Blood tests to see if the tumor secretes hormones in response to specific stimuli, including exercise, food, and various hormones. The hormones are given through an intravenous catheter, or IV a thin plastic tube inserted into an arm vein. After the stimulus, blood is drawn through the same IV every 30 minutes for up to 3 hours to measure hormone levels. Based on the results of these tests, some patients may have additional blood tests to check hormone response to special foods, an IV salt solution, or other hormones or drugs given either IV or by mouth (in pill form).
5. Photographs to document the effects on the body of abnormal hormone secretion from the adrenal tumor.
6. Small samples of blood and tumor tissue for research and DNA (genetic) analysis.

A discussion of treatment options will be based on the results of tests. If surgery to remove the tumor is recommended, the procedure can be done at NIH under this study protocol. If a malignant tumor is found that cannot be treated surgically, chemotherapy or radiation therapy may be recommended. These options are not offered under this protocol, but may be available under a different NIH study (for example, at the National Cancer Institute). Referrals will be made at the patient s request.

Patients who had surgery may be followed at the NIH outpatient clinic for 1 year after surgery. Patients with certain types of tumors may continue to be followed at NIH once a year for up to 5 years.

A registry of study participants will be created to keep records and correlate medical histories with tissues kept at NIH. The registry will also be used to inform participants of research studies they may be interested in. No individuals or organizations outside of NIH will have access to the registry.

The adrenal glands are the major source in the body of the steroid hormones. In normal physiology, the pituitary hormone ACTH regulates the secretion of glucocorticoids, while the secretion of mineralocorticoids such as aldosterone is controlled by the renin-angiotensin system. In addition to these two classes of steroids, the adrenal gland secretes lesser amounts of intermediate metabolites as well as dehydroepiandrosterone (DHEA) and its sulfated product (DHEAS) and androstenedione, testosterone, estrogen, and estrone. Dysregulated secretion of any of these hormones can be caused by sporadic adrenocortical adenomas or carcinomas, with the development of specific clinical syndromes depending on the identity of the hormones secreted. In at least a subset of cortisol-producing adrenocortical neoplasms, the presence of ectopic or abnormal receptors has been described, resulting in the regulation of cortisol and/or aldosterone by non-physiologic stimuli. The present study will serve as a mechanism to investigate individuals with steroid hormone-secreting adrenocortical tumors of all types for the purpose of identifying hereditary, congenital, or acquired defects leading not only to hormone oversecretion, but also to tumor formation. One of the first goals of the study was (until very recently) to examine the prevalence of ectopic receptor expression in cortisol- and/or aldosterone- hormone secreting adrenocortical tumors. This led to the understanding of the ontogeny of these tumors and the development of novel therapeutic strategies (e.g., receptor antagonists) to control hormone oversecretion. We currently use this information for the evaluation and treatment of our patients. An important research goal of the study is to identify novel genetic defects leading to tumors of the adrenal gland. This is done through a set of methods, from sequencing of the collected DNA to analysis of the expression of large sets of genes using gene array/gene chip analysis. This information may help to identify patients who would benefit from more aggressive intervention strategies, especially those with potentially malignant tumors. This study also provides the patient cohort necessary for the establishment of a bank of tissues of varying tumors of the adrenal cortex, which may serve in the future as an experimental resource to test new diagnostic and therapeutic methods. Finally, an important and more recent goal of this study is to investigate the effects of excess aldosterone on renal, cardiac, metabolic, and bone systems in patients with primary hyperaldosteronism, an important subgroup of patients with adrenocortical tumors. Patients with hyperaldosetronism have not been studied with the same rigor as patients with hypercortisolism in the past; this study aims at investigating the relative contribution of hyperaldosteronism in the etiopathogenesis of a number of clinical problems in patients with adrenocortical lesions and hypertension.

Study of Adrenal Gland Tumors

Clinical and Molecular Analysis of ACTH-Independent Steroid Hormone Production in Adrenocortical Tissue

-to define the germline and/or somatic genetic mutations causing ACTH-independent Cushing s syndrome -to define the biochemical functionality of mutations in adrenocortical tumor -to investigate novel therapeutic strategies to control hormone over-secretion of biochemically active adrenal tumors

to investigate co-secretion of other steroids -to investigate cardiac, renal, metabolic and coagulopathic consequences of primary aldosteronism -to investigate the clinical utility of other biomarkers in classifying adrenal disorders

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-guided FNA in the Study of the Adrenal Gland	NCT03327142	Adrenal Gland D... Adrenal Tumor	Endoscopic Ultr...	18 Years -	Hospital Universitari de Bellvitge
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome	NCT00588068	Neuroblastoma	Tumor and Marro...	-	Memorial Sloan Kettering Cancer Center
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation	NCT00997594	Adrenal Tumors	Radiofrequency ...	20 Years -	Mie University
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation	NCT00997594	Adrenal Tumors	Radiofrequency ...	20 Years -	Mie University
EUS-guided FNA in the Study of the Adrenal Gland	NCT03327142	Adrenal Gland D... Adrenal Tumor	Endoscopic Ultr...	18 Years -	Hospital Universitari de Bellvitge
Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors	NCT02239900	Liver Cancer Lung Cancer	Ipilimumab Stereotactic Bo...	18 Years -	M.D. Anderson Cancer Center
Study of Adrenal Gland Tumors	NCT00005927	Adrenal Gland N...		3 Years - 70 Years	National Institutes of Health Clinical Center (CC)

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