Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Adenoma

Pituitary Diseases

Recurrence

Central Nervous System Neoplasms

Nervous System Neoplasms

Pituitary Neoplasms

Prolactinoma

Adenoma, Basophil

Adenoma, Chromophobe

Adenoma, Acidophil

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

temozolomide

DNA methylation analysis

microarray analysis

protein expression analysis

proteomic profiling

laboratory biomarker analysis

Anthony Heaney, MD

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with invasive pituitary tumors.

OBJECTIVES:

Primary

* To assess the effect of temozolomide on pituitary tumor growth in patients with invasive pituitary tumors.
* To assess the effect of temozolomide on pituitary tumor response and the duration of tumor response in these patients.

Secondary

* To assess the effect of temozolomide on pituitary tumor hormone secretion in these patients.
* To assess the effect of temozolomide on other aspects of pituitary function in these patients.
* To assess the overall safety and tolerability of temozolomide in these patients.
* To assess the overall quality of life of patients treated with temozolomide.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of 12 courses, patients achieving a complete or partial tumor response may continue to receive temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected periodically to assess methylation status of the methyl-guanine methyl-transferase promoter (MGMT) gene and to quantitate immunocytochemical expression of the tumor suppressor proteins p53, p16, and p27. Tissue samples are also analyzed by microarray and proteomics to determine a genetic "signature" of invasive vs non-invasive pituitary tumors and to determine if this signature correlates with response to temozolomide. Blood samples are also periodically for biomarker laboratory studies.

Patients complete a quality of life questionnaire periodically.

After completion of study therapy, patients are followed for 28 days.

Temozolomide in Treating Patients With Invasive Pituitary Tumors

An Open Label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Temozolomide Treatment in Patients With Invasive Pituitary Tumors

Jonsson Comprehensive Cancer Center

Musculoskeletal Diseases

Glioma

Glioblastoma

Astrocytoma

Meningioma

Oligodendroglioma

Neoplasm Metastasis

Medulloblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Pinealoma

Ependymoma

Craniopharyngioma

Adamantinoma

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Solitary Fibrous Tumors

Hemangiopericytoma

Choroid Plexus Neoplasms

Glioma, Subependymal

Germ Cells Tumors

Acute Graft Versus Host Disease

Brain Tumor, Adult

Pineocytoma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

Diffuse Astrocytoma

Supratentorial Primitive Neuroectodermal Tumor

Pineoblastoma

Pilocytic Astrocytoma

Anaplastic Ependymoma

Embryonal Tumor With Multilayered Rosettes

Subependymoma

Myxopapillary Ependymoma

Patients complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.

Questionnaire

John Suh, MD

RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with brain tumors or other brain disorders may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This clinical trial is studying the acute side effects in patients who are undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

OBJECTIVES:

* Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.
* Determine the time frame for development and resolution of these complications in these patients.
* Determine the severity of these complications in these patients.

OUTLINE: Patients undergo stereotactic radiosurgery. Patients also complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.

Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders

Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery

Patients undergo stereotactic radiosurgery. Patients also complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.

Case Comprehensive Cancer Center

Hypoglycemic Agents

Maleic acid

Rosiglitazone

Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.

Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.

rosiglitazone maleate

RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and grow and spread more slowly.

PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed or residual or recurrent pituitary adenoma.

OBJECTIVES:

* To assess the effect of rosiglitazone maleate on the core biochemical parameter, 24-hour urinary free cortisol levels, in patients with recurrent or uncured pituitary-dependent Cushing disease. (Group 1)
* To assess the effect of this drug on corticotropin-releasing hormone-stimulated pituitary tumor ACTH secretion in patients with recurrent or uncured pituitary-dependent Cushing disease. (Group 1)
* To assess the effect of this drug on tumor growth in patients with non-secreting pituitary macroadenoma (\> 10 mm) using RECIST criteria. (Group 2)
* To assess the effect of this drug on pituitary tumor gonadotropin (i.e., follicle-stimulating hormone, leuteinizing hormone, and alpha-subunit) secretion in patients with non-secreting macroadenoma. (Group 2)
* To assess the overall safety and tolerability of this drug in both cohorts of patients.
* To assess the overall quality of life, in terms of performance status during treatment, of both cohorts of patients using the Karnofsky performance index.

OUTLINE: Patients are grouped according to adrenocorticotropic hormone (ACTH)-secreting status (yes \[Group 1\] vs no \[Group 2\]).

* Group 1 (ACTH-secreting adenomas): Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
* Group 2 (non-secreting macroadenomas): Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.

Patients undergo collection of blood and urine samples at baseline and after completion of study therapy to assess pituitary function, thyroid function, and 24-hour urinary free cortisol levels. Additional assessments include corticotrophin-stimulation testing, dynamic pituitary function testing (i.e., arginine/growth-hormone releasing-hormone testing) to measure growth hormone secretion, and overnight 1 mg dexamethasone suppression testing to measure 8 a.m. serum cortisol levels. Patients also undergo MRI at baseline and after completion of study therapy to examine the effects of rosiglitazone maleate treatment on pituitary tumor size.

Patients complete a questionnaire at baseline and monthly during study for evaluation of headaches.

PROJECTED ACCRUAL: A total of 15 patients with ACTH-secreting pituitary tumor and 15 patients with non-secreting pituitary macroadenomas will be accrued for this study.

Rosiglitazone in Treating Patients With Pituitary Tumors

Rosiglitazone (Peroxisome Proliferating Activating Receptor-gamma {PPAR-y} Ligand) Treatment of Pituitary Tumors

Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.

National Institutes of Health (NIH)

Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.

rosiglitazone maleate : Given orally

Group 1 (ACTH-secreting Adenomas)

Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.

rosiglitazone maleate : Given orally

Group 2 (Non-secreting Macroadenomas)

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Recruitment was the main limitation. Patients were available but were not interested in the study due to possible side effects of the study drug.

Anthony Heaney, M.D. Ph.D

No data was analyzed for this outcome measure as there was insufficient data to perform analysis.

Efficacy of Rosiglitazone Maleate on Cushing Disease

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Infections

Digestive System Diseases

Substance Related Disorders

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Syndrome

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Lymphoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma, Non-Hodgkin

Melanoma

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Lymphoma, B-Cell

Burkitt Lymphoma

Carcinoid Tumor

Carcinoma, Islet Cell

Insulinoma

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Gastrinoma

Glucagonoma

Somatostatinoma

Zollinger-Ellison Syndrome

Malignant Carcinoid Syndrome

Serotonin Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Adenoma, Islet Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neuroendocrine Tumors

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Gastrointestinal Diseases

Pancreatic Neoplasms

Pancreatic Diseases

Small Cell Lung Cancer

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Hodgkin Lymphoma

Pancreatic Neuroendocrine Tumor

Gastrointestinal Agents

Somatostatin

Edotreotide

Pancreatic Polypeptide

Radiopharmaceuticals

yttrium Y 90-edotreotide

Larry K. Kvols, MD

RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of yttrium Y 90-SMT 487 in patients with recurrent malignant neoplasms that prove positive for somatostatin receptors. II. Determine the safety and lifetime serious adverse event profile of this regimen in these patients. II. Determine the antitumor effect and the effect of repeated administrations on the renal excretion pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients undergo octreotide scintigraphy to determine the location of somatostatin receptors. Patients then receive yttrium Y 90-SMT 487 IV over 15 minutes on day 1. Treatment continues every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are entered on course I (vertical dose escalation) and courses II, III, and IV (horizontal dose escalation). Cohorts receive escalating doses of yttrium Y 90-SMT 487 until the maximum tolerated dose (MTD) is determined. MTDs are determined for a single course and for 4 courses. The MTD is defined as the dose preceding that at which no more than 2 of 6 patients experience dose limiting toxicities. Results of course I determine the dosage of subsequent courses. Patients are evaluated on days 2 and 7, and at weeks 4 and 6, following each injection of yttrium Y 90-SMT 487. Patients are followed at 12 and 18 months and then annually thereafter.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer

A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors

Novartis Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Temozolomide in Treating Patients With Invasive Pituitary Tumors	NCT00601289	Brain and Centr...	temozolomide DNA methylation... microarray anal... protein express... proteomic profi... laboratory biom...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders	NCT00255671	Brain and Centr... Metastatic Canc... Radiation Toxic...	Questionnaire	18 Years -	Case Comprehensive Cancer Center
Rosiglitazone in Treating Patients With Pituitary Tumors	NCT00616642	Brain and Centr...	rosiglitazone m...	18 Years - 65 Years	Jonsson Comprehensive Cancer Center
Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer	NCT00006368	Brain and Centr... Breast Cancer Gastrointestina... Islet Cell Tumo... Lung Cancer Lymphoma Melanoma (Skin) Neoplastic Synd...	yttrium Y 90-ed...	18 Years -	Novartis
Temozolomide in Treating Patients With Invasive Pituitary Tumors	NCT00601289	Brain and Centr...	temozolomide DNA methylation... microarray anal... protein express... proteomic profi... laboratory biom...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
Rosiglitazone in Treating Patients With Pituitary Tumors	NCT00616642	Brain and Centr...	rosiglitazone m...	18 Years - 65 Years	Jonsson Comprehensive Cancer Center

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