Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Rare Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Meningioma

Oligodendroglioma

Neoplasm Metastasis

Pituitary Diseases

Brain Diseases

Central Nervous System Neoplasms

Medulloblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Nervous System Neoplasms

Pinealoma

Pituitary Neoplasms

Ependymoma

Craniopharyngioma

Adamantinoma

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Solitary Fibrous Tumors

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Pineocytoma

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Pineoblastoma

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Embryonal Tumor With Multilayered Rosettes

Subependymoma

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All Drugs and Chemicals

Hormones

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

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

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

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System 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	Link
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
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

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