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Adrenal Cortex Neoplasms clinical trials

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NCT ID: NCT01528956 Completed - Clinical trials for Adrenocortical Carcinoma

Studying Genes in Samples From Younger Patients With Adrenocortical Tumor

Start date: February 2012
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.

NCT ID: NCT01255137 Completed - Clinical trials for Adrenal Cortex Neoplasms

Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer

Start date: September 2010
Phase: Phase 2
Study type: Interventional

Background: - Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the top of the kidneys. It has a low survival rate if standard treatment options are not effective. Axitinib is an experimental drug that is being studied to determine if it can stop tumors from growing or make them smaller. Researchers are interested in investigating axitinib in individuals with aggressive or otherwise untreatable adrenocortical cancer. Objectives: - To evaluate the effectiveness of axitinib in individuals who have adrenocortical cancer that is inoperable and has not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have been diagnosed with adrenocortical cancer that has not responded to standard treatments. Design: - Participants will be screened with a full physical examination and medical history, as well as tumor imaging studies. - Participants may have a tumor biopsy prior to starting axitinib. - All participants will receive axitinib to take twice a day with food for 28 days (1 cycle). Participants should not drink grapefruit juice or smoke cigarettes while participating in this study. - After the first cycle, the dose may be increased and additional cycles will be given if the treatment has not had serious side effects. - Participants will have regular examinations while taking axitinib, including blood samples and tumor imaging studies to determine if the tumor has stopped growing. Blood pressure levels will be carefully monitored during treatment to evaluate potential risk for high blood pressure. - Participants may have a second tumor biopsy 20 to 30 days after treatment begins. - Treatment will continue as directed by the study researchers.

NCT ID: NCT00768365 Completed - Clinical trials for Adrenal Cortex Neoplasms

Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma

adrenal
Start date: October 2007
Phase: N/A
Study type: Observational

Between September 2006 and September 2008, 35 patients (32 women and 3 men; mean age 49years with adrenal incidentaloma (AI) were prospectively evaluated at the Department of Endocrinology and General Surgery of Istanbul University, Istanbul Medical Faculty. All patients with AI underwent physical examination, including waist circumference. Body mass Index (BMI) was calculated as weight (kg)/ height (m) squared. A BMI > 30 was considered an index of obesity. A waist circumference > 88 cm in women and > 95 cm in men was considered the cutoff for visceral obesity in accordance to the Adult Treatment Panel III (ATP III) metabolic syndrome criteria. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured from the right brachial artery of the patients in a supine position after 10 minutes of rest by using a pneumatic sphygmomanometer by the same doctor.

NCT ID: NCT00304070 Completed - Clinical trials for Stage II Adrenal Cortical Carcinoma AJCC v7

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

Start date: May 3, 2007
Phase: Phase 3
Study type: Interventional

This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

NCT ID: NCT00071058 Completed - Clinical trials for Adrenal Cortex Neoplasms

Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical Cancer

Start date: October 2003
Phase: Phase 2
Study type: Interventional

This study will examine the safety and effectiveness of treating adrenocortical cancer with combination chemotherapy using doxorubicin, vincristine, and etoposide in addition to the drugs mitotane and tariquidar and, when possible, surgery. Adrenocortical cancer cells have a large amount of a protein called P-glycoprotein that "pumps" anti-cancer drugs out of the cells, decreasing their effectiveness. Continuous infusions of doxorubicin, vincristine, and etoposide may improve chemotherapy results by blocking the P-glycoprotein pump, as may use of tariquidar, an experimental drug that is known to block the P-glycoprotein pump. Patients 18 years of age and older with adrenocortical cancer that has recurred, spread, or cannot be treated surgically may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood tests; electrocardiogram (EKG); imaging tests, including computed tomography (CT) of the chest, abdomen and pelvis; chest x-ray; and possibly a bone scan or other imaging tests needed to evaluate the cancer, urine studies, and an echocardiogram. Also, a biopsy (removal of a small sample of tumor tissue) may be required if a specimen is not available to confirm the cancer. Participants will undergo the following tests and procedures: - Tumor biopsy. Before starting chemotherapy, a small piece of tumor is removed to study the P-glycoprotein pump and to determine the tumor genetics. - Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. - Central venous catheter placement. A specially trained physician places a plastic tube into a major vein in the chest. The tube is used to give the study drugs and other medications and to withdraw blood samples. It can stay in the body for months or be removed after each treatment is completed. The tube placement is done under a local anesthetic in the radiology department or operating room. - Chemotherapy. Treatment cycles are 21 days. Doxorubicin, vincristine, and etoposide are given through the central venous catheter by an infusion pump continuously over 96 hours starting day 1 of each cycle. The dose of these drugs may be increased or decreased from cycle to cycle, based on side effects. Mitotane is given in pill form starting day 1 of cycle 1 and is taken every day throughout the entire study. The mitotane dose is gradually increased as long as the side effects are tolerable. Tariquidar is given through the central venous catheter as a 30-minute infusion on days 1 and 3 of every cycle. The tariquidar dose remains the same throughout the study. Treatment will continue for two cycles after all the cancer is gone, or until surgery is done to remove some or all of the remaining cancer, or, if surgery is not an option, until the cancer has grown to where it is defined as progressive disease. - Nuclear scans. A nuclear scan is done before treatment begins and again on day 1 or day 3 of the first treatment cycle after administration of tariquidar to evaluate the P glycoprotein response to treatment. - Computed tomography (CT) scans. These scans are done every two treatment cycles to follow disease progress. - Surgery. Surgery to remove areas of cancer may be considered at any point during the study (including before beginning treatment), if it is deemed beneficial. Treatment with the study drugs will begin or resume after surgery. The length of treatment will depend on the response to treatment before the surgery and on whether there is any cancer remaining after the surgery.