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Adrenal Mass

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3561. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

renal cell carcinomas allowed No pure sarcomas No collecting duct (duct of Bellini) tumors, oncocytomas, or transitional cell tumors Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Nonmeasurable lesions include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Patients with known brain metastases (...) No concurrent hormones (e.g., megestrol) except steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy to any lesion that may produce disability (e.g., unstable femur) allowed No concurrent palliative radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior major surgery

2002 Clinical Trials

3562. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Primary bladder masses Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies No prior or concurrent CNS metastases Negative MRI of the brain within the past 28 days Must have HLA-identical (6/6 (...) sargramostim (GM-CSF) Concurrent epoetin alfa allowed Chemotherapy: No other concurrent chemotherapy Endocrine therapy: At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy) Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy: At least 14 days since prior radiotherapy Surgery: At least 14 days since prior surgery Other: At least 28 days since prior

2001 Clinical Trials

3563. Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

neuroblastoma are also eligible All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include: Following treatment per A3973 protocol Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol Following treatment per CCG3891

2001 Clinical Trials

3564. A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer

Adult Sexes Eligible for Study: Male Accepts Healthy Volunteers: No Criteria Inclusion Criteria Each subject must meet the following inclusion criteria to be eligible for enrollment in the study: Histologic diagnosis (recent or remote) of prostate adenocarcinoma Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following: Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical (...) , or abstinence. Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be enrolled in the study: Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment Use of PC-SPES (herbal supplement) within 4 weeks of enrollment Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment Prior monoclonal antibody administration

2003 Clinical Trials

3565. PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions No known brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN (...) therapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery See Disease Characteristics At least 2 weeks since prior major surgery Other At least 30 days since prior investigational agents At least 7 days since prior grapefruit or grapefruit juice At least 7 days since prior CYP3A4

2003 Clinical Trials

3566. Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)

-ray) OR 10 mm by spiral CT scan or MRI The following are considered nonmeasurable disease: Small lesions Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Irradiated lesions, unless progression is documented after radiotherapy RCC paraffin tissue blocks or unstained slides must be available No evidence of prior or concurrent CNS metastases by MRI or CT scan (...) corticosteroid therapy except the following: Topical and inhaled steroids Replacement therapy for adrenal insufficiency No concurrent hormones except those administered for nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated No concurrent palliative radiotherapy Surgery

2003 Clinical Trials

3567. Vaccine Treatment for Advanced Non-Small Cell Lung Cancer

that are accessible to needle, punch or other limited biopsy, be at low risk for biopsy and be willing to undergo tumor core needle biopsy, punch or other similar biopsy pre-vaccination and again post-vaccination. Such sites may include skin and soft tissue metastases, adrenal gland metastases, peripheral lymph nodes (supraclavicular, axillary, or inquinal), a pulmonary lesion at low risk for complications defined as lesions greater than 1.5 cm surrounded by aerated lung, pleural based masses greater than 1.5 cm

2003 Clinical Trials

3568. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor

). [ Time Frame: Up to 5 years ] Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass (...) % confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Secondary Outcome Measures : Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment

2002 Clinical Trials

3569. Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions in a previously irradiated area No clinically suspected or confirmed supraclavicular lymph node metastases No pleural effusions visible on plain chest radiographs, regardless of cytology PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified (...) and be considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) during consolidation therapy Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except: Steroids for adrenal failure Hormones for non-disease-related conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial

2002 Clinical Trials

3570. CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

by CT scan or MRI OR at least 1.5 cm by physical exam One of the following measurement parameters may be used: Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm^3 No known CNS involvement (parenchymal mass or leptomeningeal involvement) Performance status - ECOG 0-2 At least 3 months See Disease Characteristics (...) Disease Characteristics See Biologic therapy At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy for MCL Concurrent corticosteroids for adrenal insufficiency allowed See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy for MCL Any number of prior treatments allowed No other concurrent investigational or commercial agents for MCL No concurrent drugs that induce cytochrome p450

2002 Clinical Trials

3571. Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions in a previously irradiated field PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 2 (...) No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics Radiotherapy: See Disease Characteristics No prior radiotherapy for NSCLC Surgery: At least 2 weeks since prior exploratory thoracotomy Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your

2002 Clinical Trials

3572. Effects of Dietary Carbohydrate and Fat on Hormones

Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will try to determine if intake of dietary fats or carbohydrates influences the tendency to gain weight or accumulate body fat. It will examine how the hormones that regulate weight may change with a shift from a balanced diet to one that is low in fat or carbohydrate, irrespective of caloric intake. Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kg/m2 may be eligible (...) , pituitary, ovarian/testicular and adrenal problem Acute infections Irregular menstrual cycles (greater than 7 day menses, intervals greater than 35 or less than 21 days) A weight change of greater than 2% within the past 2 months. Use of prescription medications or other drugs/supplements including acetaminophen or alcohol that would, in the judgement of study investigators, interfere with study objectives Major (greater than 3 hours/week) athletic/physical exercise activities. Eating patterns

2001 Clinical Trials

3573. Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid

Drug: Cholic Acids 10-15 mg/kg body weight/day taken orally. Other Names: Cholic Cholic Acid Cholic Acid Capsules Outcome Measures Go to Primary Outcome Measures : Determination of changes in synthesis of atypical bile acids in urine by mass spectrometry (FAB MS) [ Time Frame: 12 months ] Secondary Outcome Measures : Change in Liver Function Test (serum transaminases) [ Time Frame: Standard of Care ] Change in Liver Histology (for patients in whom biopsy was performed) [ Time Frame: Standard (...) Disorders, Nervous System Metabolism, Inborn Errors Metabolic Diseases Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Liver Diseases

2000 Clinical Trials

3574. Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions Performance status - CTC 0-2 WBC at least 2,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Creatinine no greater than 2.0 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No baseline neuropathy or cerebellar dysfunction greater than grade 1 At least 4 weeks since prior immunotherapy No prior (...) carboxyamidotriazole No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Concurrent epoetin alfa allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes) At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy See Disease Characteristics At least 4 weeks since prior surgery Contacts and Locations Go to Information from

2000 Clinical Trials

3575. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer

: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) No concurrent chemotherapy Endocrine therapy: At least 24 hours since prior steroids No concurrent steroids including steroid therapy for documented adrenal failure or septic shock Concurrent noncorticosteroid hormones for nonmalignancy conditions allowed Radiotherapy: At least 4 weeks since prior extensive radiotherapy No concurrent radiotherapy to measurable malignant masses Surgery: Not specified Other: At least 24

2000 Clinical Trials

3576. Once-A-Month Steroid Treatment for Patients With Focal Segmental Glomerulosclerosis

distribution- baseline and 8 months Eye examinations for cataracts and glaucoma - baseline and 8 months Bone density scan (DEXA scan) of the lower spine and hip - baseline, 4 and 12 months Magnetic resonance imaging (MRI) of the hips Psychological evaluation and quality of life evaluation - baseline, 1, 2 and 8 months Blood tests for adrenal gland function - baseline, 4 and 8 months Blood and urine tests - 10, 12, 15, and 18 months Patients who achieve remission (whose urine protein levels decrease (...) Ages Eligible for Study: Child, Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria INCLUSION CRITERIA: Adults and children. Biopsy proven FSGS, including idiopathic FSGS and collapsing FSGS, but excluding HIV-associated FSGS and secondary FSGS associated with morbid obesity, sickle cell anemia, reflux nephropathy, chronic tubular injury, congenital renal anomalies, and reduced nephron mass. Glomerular filtration rate will be estimated using 4 variable MDRD GFR

2000 Clinical Trials

3577. Heart Disease Risk Factors in Major Depression

resistance in each patient and control, we will apply the hyperinsulinemic euglycemic glucose clamp procedure. This is the gold standard method for measuring the insulin sensitivity since it reflects the direct human body glucose metabolic response to a known insulin infusion. Moreover, it is essential to use this technique in patients with major depression as data indicate that other alternative procedures give unreliable results in the context of hypercortisolism. Condition or disease Adrenal Gland (...) . Subjects should not have significant underlying illnesses known to affect insulin sensitivity, and should have a body mass index between 20 and 30 kg/m2. EXCLUSION CRITERIA Pregnancy Existing diabetes mellitus Body mass index less than 20 or greater than 30 kg/ m2 Existing cardiovascular diseases and other end organ diseases Existing peripheral vascular disease HIV infection Patients who are on B-blockers, thiazides, and/or glucocorticoids and cannot discontinue these medications. Subjects who

2000 Clinical Trials

3578. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

, Layout table for eligibility information Ages Eligible for Study: Child, Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically confirmed Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy Core biopsy is acceptable if adequate tissue is obtained for primary diagnosis and immunophenotyping Bone marrow biopsy is not acceptable as sole means of diagnosis Measurable disease Tumor mass greater than 1 cm (...) contraception PRIOR CONCURRENT THERAPY: No prior gemcitabine, vinorelbine, or doxorubicin HCl liposome No other concurrent chemotherapy Endocrine therapy: No concurrent hormones except for nondisease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure No concurrent dexamethasone or other steroidal antiemetics Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using

2000 Clinical Trials

3579. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

in patients who have cancer-related weight loss. Condition or disease Intervention/treatment Phase Cachexia Fatigue Unspecified Adult Solid Tumor, Protocol Specific Drug: megestrol acetate Procedure: physical therapy Phase 2 Detailed Description: OBJECTIVES: I. Determine the effect of megestrol and progressive resistance training on lean body mass, total body weight, functional capacity, appetite, and fatigue in patients with weight loss due to advanced malignancy. OUTLINE: This is a multicenter study (...) hyperalimentation No contraindications to megestrol No dementia or mental incompetence No known AIDS Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent adrenal steroids (other than for replacement), anabolics, appetite stimulants, or progestational agents Intermittent corticosteroids as antiemetic or premedication for cancer treatment allowed At least 6 weeks since prior megestrol Radiotherapy

2000 Clinical Trials

3580. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions No CNS metastases Performance status - ECOG 0-2 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN LVEF at least 45% (by echocardiogram or MUGA) Not pregnant or nursing Fertile patients must use effective contraception HIV negative No concurrent (...) immunologic disease (e.g., autoimmune disease) No history of allergy to murine products No prior murine antibodies No prior anthracyclines No more than 1 prior chemotherapy regimen for lung cancer At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) At least 6 months since prior radiotherapy No concurrent

2000 Clinical Trials

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