Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Musculoskeletal Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Lung Neoplasms

Sarcoma

Lymphoma

Melanoma

Spinal Diseases

Urogenital Diseases

Spinal Neoplasms

Bone Neoplasms

Bone Diseases

Soft Tissue Sarcoma

Lymphosarcoma

Radiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.

Three radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.

Radiation Therapy

Amol J. Ghia, MD

The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.

CT-On-Rails or Trilogy is a system that places the radiation treatment machine in the same room as the CT scanner so that the CT scanner can help deliver radiation more precisely.

You will have a MRI of the spine within 1 month of registration on this study. You will also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief Pain Inventory (5 minutes) within 1 week of registration.

A pretreatment feasibility study will first be performed to determine the precision, accuracy, and reproducibility with which the target volume and critical normal structures (e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this will consist of a CT scan.

Patients will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep the patient from moving during scanning and later treatment.

You will be asked questions about your medical history and have a complete neurological exam during your first consultation. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, mental exam, and way you walk. MRI of the spine must be performed within 1 month of registration. You will be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete, and should be completed within 1 month of being enrolled in the study.

All patients will be treated with radiation therapy that is guided by the CT-on-Rails or Trilogy procedure. Patients will receive a CT scan immediately before the treatment in the same room of the treatment using CT-On-Rails or Trilogy. There will be a total of 3 treatments over a period of 2 weeks.

Monitoring of side effects will be focused on neurological, gastrointestinal, musculoskeletal, and hematological systems. Every attempt will be made to have the patient complete the prescribed course of radiation to maximize the beneficial effect of treatment. However, if there is severe side effects, radiation treatment will be stopped and patients will be taken off study.

You will have follow up visits once a week during radiation treatment, scheduled on the same day as radiation. After treatment, you will have telephone, mail, or follow-ups per fax scheduled at 2 and 4 weeks,and 2 months post radiation. You will have follow up visits scheduled at 3, 6, 9, 12, 18, and 24 months, then every six months for the rest of your life. At all follow-up visits, you will be asked questions about your medical history, have a neurological exam, and neurologic function will be evaluated. Any pain medication you are taking will be noted. You will have an MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your life. You will also be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete.

This is an investigational study. The CT-on-rails and Trilogy linear accelerator are FDA-approved medical devices and are commercially available, however, the way these two devices are being used is investigational. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.

Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)

Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease

The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief is the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.

M.D. Anderson Cancer Center

Infections

Symptoms and General Pathology

Digestive System Diseases

Kidney Diseases

Autoimmune Diseases

Hematologic Neoplasms

Communicable Diseases

Gastrointestinal Diseases

Intestinal Diseases

Hematologic Diseases

Disease Attributes

Healthy subjects with no history of chronic disease

Subjects that have been diagnosed with a condition of interest such as Diabetes, NASH, Breast Cancer, Endometriosis, or other designated condition.

Observational Study Only. NO Intervention.

Study purpose: to explore the entire spectrum of proteomic and genomic changes (amongst others) involved in diseases and in healthy/control populations. The Study is designed to discover biomarkers, develop and validate diagnostic assays, instruments and therapeutics as well as other medical research. Specifically, researchers may analyze proteins, RNA, DNA copy number changes, including large and small (1,000-100,000 kb) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both diseased tissue and case-matched germline DNA from Subjects.

The primary objective of this Study is to collect high-quality tissue, whole teeth, and biofluid Specimens, and associated Clinical Data from consented Subjects.

The secondary objective of this Study is to test Specimens and associated Clinical Data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess RNA and DNA integrity or degradation, and provide overall quality control evaluations.

This Study will collect leftover Specimens that are taken during standard medical care procedures (for example, tissues, whole teeth, blood, saliva, urine, fluids, and cells). Samples will first be processed for clinical purposes, and any discarded portions of the Specimen(s) will be provided to the Sponsor for the Study purposes.

Non-Surplus Specimens Types to be Collected for Study:

Blood Tooth Bone marrow aspirate Aqueous humor Urine Perineal specimens Rectal specimens Urethral specimens Nasal/Nasopharyngeal and throat specimens Cheek (buccal) specimens Saliva (Sputum) Oral rinse Stool samples Vaginal and cervical specimens Endometrial (uterus) samples Vaginal lavage (wash)

AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)

We will total the number of subjects and characterize the totals by disease state, gender, ethnicity and specimens contributed

Audubon Bioscience

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Germ Cells Tumors

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

Sunitinib Malate

Lance Pagliaro, MD, BA

The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.

The Study Drug:

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

Within 14 days of enrollment on this study, you will have the following tests and procedures performed:

* Your complete medical history will be recorded.
* You will have a physical exam.

Within 7 days of enrollment on this study, you will have the following tests and procedures performed:

-Blood (about 3 teaspoons) and urine will be collected for routine testing and to test for certain biomarkers (to check the status of the disease).

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take sunitinib malate capsules once a day (by mouth) for 4 weeks in a row followed by 2 weeks with no study drug. These 6 weeks are considered 1 cycle of study treatment.

Study Visits:

On Day 1 of each cycle (about every 6 weeks), you will have the following tests done before you take the study drug:

* You will have a physical exam.
* You will be asked about how you are feeling and about any side effects you have experienced since your last visit.
* You will have blood (about 3 teaspoons) and urine collected for routine tests and to test for certain biomarkers.

For the first 4 weeks of treatment, you should have your blood pressure monitored. This may be done at your home with a digital pressure device, or you may visit your local doctor for this testing.

About Day 21 of Cycles 1 and 2, blood (about 2- 3 teaspoons) will be drawn for routine tests. This may be done at your local doctor's office and results faxed to the study doctor.

On Day 1 of Cycle 2, Day 1 of Cycle 3, and then Day 1 of every 2 cycles after that (Cycle 5, Cycle 7, and so on), you will have imaging scans to check status of the disease. This could include CT or MRI scans, an ECG, and a chest x-ray. If your doctor thinks it is necessary, you may have additional imaging scans at any time.

On Day 1 of every other cycle (Cycle 3, Cycle 5, and so on), you will have an echocardiogram or MUGA scan.

Length of Study:

You may remain on study for as long as you are benefitting. You will be taken off study if intolerable side effects occur or if the disease gets worse. However, if the disease gets worse very quickly during Cycles 1 or 2, you will be taken off study at that time.

Off-Study Visit:

When you are taken off of treatment on this study, the following tests and procedures will be performed:

* You will have a physical exam.
* You will be asked how you are feeling and about any changes in your medical history since beginning this study.
* You will also be asked about any side effects you have experienced since your last visit.

This is an investigational study. Sunitinib malate is approved by the FDA for the treatment of adults with kidney cancer. Its use in patients with germ cell tumors is investigational. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.

Sunitinib Malate in Refractory Germ Cell Tumors

Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors

Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)	NCT00508443	Spinal Neoplasm...	Radiation Thera...	-	M.D. Anderson Cancer Center
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)	NCT05889806	Oncology Hematologic Mal... Gastro-Intestin... Autoimmune Dise... Pregnancy Relat... Infectious Dise... Cardiovascular ... Genitourinary D... Renal Disease	Observational S...	18 Years -	Audubon Bioscience
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)	NCT05889806	Oncology Hematologic Mal... Gastro-Intestin... Autoimmune Dise... Pregnancy Relat... Infectious Dise... Cardiovascular ... Genitourinary D... Renal Disease	Observational S...	18 Years -	Audubon Bioscience
Sunitinib Malate in Refractory Germ Cell Tumors	NCT00912912	Genitourinary D...	Sunitinib Malat...	18 Years -	M.D. Anderson Cancer Center
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)	NCT00508443	Spinal Neoplasm...	Radiation Thera...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for genitourinary disease