Diseases and Abnormalities at or Before Birth

All Conditions

Heart and Blood Diseases

Congenital Abnormalities

Arteriovenous Malformations

Vascular Malformations

Cardiovascular Abnormalities

Vascular Diseases

Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.

Phase I: 20-25 Gy in 5 fractions

Phase II: 9-24 GY in 1 fraction

Radiosurgery

John B. Fiveash, M.D.

Phase I of the study (motion and quality assurance \[QA\] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study.

Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:

Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = \<50% CTV dose/No previous RT = \<80% CTV dose.

Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.

# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.

\*Previous RT:

* greater than six months since completion of RT
* at least 20 Gy, but no more than 50 Gy

A Phase II Study of Spinal Radiosurgery

Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as "worse", "stable", "better", or "completely resolved". In the reporting "better" or "completely resolved" indicates response to treatment.

CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.

Lack of tumor growth by CT or MRI at last follow-up

Health Services Foundation

The Kirklin Clinic at Acton Road

University of Alabama at Birmingham

Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology

Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.

Radiosurgery: Phase I: 20-25 Gy in 5 fractions

Phase II: 9-24 GY in 1 fraction

Spinal Radiosurgery

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

John Fiveash, MD

Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy

Assess the Acute and Late Toxicity of Spinal Radiosurgery

Number of Participants With Lack of Tumor Growth at Last Follow-up

Overall Study

Digestive System Diseases

Symptoms and General Pathology

Diverticulum

Diverticular Diseases

Gastroenteritis

Gastrointestinal Diseases

Pathological Conditions, Anatomical

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients in this limb receive epidural analgesia

epidural

Patients in this limb receive a PCA for their pain control

Patients in limb will receive spinal analgesia

Spinal

Bruce F Levy, MRCS

Tim Rockall, FRCS

The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. The second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.

Patients will be randomized into one of 3 groups - A, B or C. In order to remove the major confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted in order to achieve fluid optimisation. Each group will then either have an epidural, spinal or a PCA for post operative analgesia depending on the randomisation. All patients will follow a common postoperative care pathway to standardize the other factors.

Patients will be asked to report parameters including pain visual analogue score (VAS) chart three times a day. Recovery of bowel functions (passage of flatus, bowel movement, and diet intake), additional analgesia consumption, time to first ambulation, analgesia related side-effects and time to discharge will be recorded.

In addition whilst the patients fluid status is optimized during surgery with the oesophageal Doppler, the physiological changes that occur with the steep trendelenberg position and the pneumoperitoneum will be recorded.

Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.

Minimal Access Therapy Training Unit

Bruce Levy

Wounds and Injuries

Neoplasms

Musculoskeletal Diseases

Fractures, Bone

Neoplasm Metastasis

Pain

Spinal Diseases

Neoplastic Cells, Circulating

Fractures, Compression

Neoplastic Processes

Bone Diseases

A small fluid balloon will create a hole in the broken back bone where tumor is located. After balloon deflation and removal, hole is filled with medical cement.

Kyphoplasty

Medical cement will be injected into broken back bone.

Vertebroplasty

Removes tissue (soft tissue, bone tissue, or both, but this will vary from person to person), including all or part of the cancerous tumors in the area of the broken back bone(s).

Cavity SpineWand

Dawid Schellingerhout, MD

Phase 1 - Optimization Phase:

Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and Kyphoplasty procedures relative to baseline CTCB.

Phase 2 - Comparison Phase:

Primary Objective: The primary objective of Phase 2 of this study is to determine the change in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to compare the average change between treatment groups with and without the use of the Cavity SpineWand.

Secondary Objectives:

* To determine the change in self-reported pain level from baseline to post-treatment as measured using the visual analogue scale (VAS) for spine pain and to compare the average change in pain level between treatment groups.
* To determine the change in pain status from baseline to post-treatment as measured using the Brief Pain Inventory (BPI) and to compare the average change in pain status between treatment groups.
* To determine the change from baseline to post-treatment in the M.D. Anderson Cancer Center Symptom Inventory (MDASI) and to compare the average change between treatment groups.
* To determine the change from baseline to post-treatment in time to walk a 50-foot distance and to compare the average change between treatment groups.

Kyphoplasty and Vertebroplasty:

Kyphoplasty and vertebroplasty are types of surgery that are used to treat broken bones in the back, which may have been caused by cancer. Both procedures involve injecting a mixture of medical cement into the broken bone(s) in the back. The cement is designed to harden and become a permanent part of the bone, supporting the bone like an "internal cast" that brings it back to its original shape. The amount of cement will vary from person to person, but it could be, for example, anywhere from a fraction of a teaspoon to a full teaspoon.

The main difference between the 2 procedures is that kyphoplasty involves the use of a small medical type of balloon, and vertebroplasty does not use balloons. Vertebroplasty also uses a slightly smaller needle to inject the cement.

The Study Device:

The Cavity SpineWand is a rod-shaped surgical tool that is designed to use a type of energy called plasma in order to destroy tissue at lower temperatures than other surgical methods. This may help to lessen damage to other nearby tissue.

In this study, the Cavity SpineWand will be used to remove tissue (soft tissue, bone tissue, or both, but this will vary from person to person), including all or part of the cancerous tumors in the area of the broken bone(s). This is designed to make extra room for the cement to be injected, either during the vertebroplasty procedure or the kyphoplasty procedure.

Screening Tests:

Before you can receive treatment in this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. If you have had some of these tests done recently, they may not need to be repeated. This will be up to your study doctor. The following tests may be performed:

* Your medical history will be recorded.
* You will have a magnetic resonance imaging (MRI) scan and a computed tomography (CT) scan. These scans will show pictures of your broken back bone(s) and the tumor. Your doctor will use these pictures to plan your surgery.

Women who are able to have children must have a negative urine pregnancy test.

Doctors currently do not fully understand whether kyphoplasty or vertebroplasty is better for treating broken bones in the back. For this reason, and because this study involves randomly assigning participants to receive one or the other of these procedures, all participants must be eligible for both procedures in order to take part in this study.

Treatment Groups:

If you are found to be eligible to take part in the study, you will be assigned to a treatment group. In each phase of the study, there is an equal chance of being assigned to any of the treatment groups.

If you are one of the first 20 patients enrolled in the study, you will be enrolled in Phase 1. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Phase 1 Group 1 will receive vertebroplasty, and Phase 1 Group 2 will receive kyphoplasty.

If you are one of the next 60 patients to be enrolled, you will be enrolled in Phase 2. You will be randomly assigned (as in the toss of dice) to 1 of 4 groups. Phase 2 Group 1 will receive vertebroplasty, and Phase 2 Group 2 will receive vertebroplasty with the Cavity SpineWand. Phase 2 Group 3 will receive kyphoplasty, and Phase 2 Group 4 will receive kyphoplasty with the Cavity SpineWand.

Study Tests/Procedures Before Surgery:

Within about 2-4 weeks before surgery, you will have tests and procedures performed. If you had some of these tests done recently, they may not need to be repeated. The following procedures may be performed:

* Your medical history will be recorded.
* You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will complete questionnaires that ask about the back pain and any drugs you are taking. In total, the questionnaires should take about 10-20 minutes to complete.
* You will be asked to walk 50 feet at your own pace while being timed to see how long it takes you. This is a routine test for comparing your walking function before and after surgery.

You will sign a separate consent form for surgery and the drugs used during surgery. These drugs include antibiotics to help lower the risk of infection, drugs to control pain, local anesthesia to make the area of your back where you are having surgery feel numb, and a sedative to make you feel relaxed and sleepy. The risks of these drugs will be explained to you in detail at that time.

Blood Test on the Day of Surgery:

On the day of surgery, blood (about 1 tablespoon) will be drawn. This blood will be compared with the blood that is drawn after surgery, to see when after surgery the most tumor cells are found in the blood.

Other Procedures Before Surgery:

As is standard for these types of surgery, special "bone" needles will be placed into the broken bone(s) in your back. X-rays will be used to guide the needles into a safe position. A biopsy of the tumor in your back bone will be collected to check the diagnosis of cancer. To collect a biopsy, a small amount of tumor tissue is withdrawn through the bone needle.

Surgical Procedures:

If you are in Phase 2 Group 2 or Phase 2 Group 4, the Cavity SpineWand will be used to remove a small amount of tissue immediately before the kyphoplasty or vertebroplasty procedure.

If you are in Phase 1 Group 2, Phase 2 Group 3, or Phase 2 Group 4, the kyphoplasty procedure will be done next. A small balloon will be placed into the area in your back where the tumor is located. Fluid will then be pumped through the tube in order to fill the balloon, which will create a hole in the back bone. After the balloon is deflated (closed) and removed, this hole will then be filled with cement. X-rays will be used to help place the cement safely.

If you are in Phase 1 Group 1, Phase 2 Group 1, or Phase 2 Group 2, the vertebroplasty procedure will be done next (instead of the kyphoplasty). Cement will be injected into the back bone. X-rays will be used to help place the cement safely.

No matter which treatment group you are in, if you have more than 1 broken back bone that needs treatment, the procedures described above will be repeated for a second broken bone, right after your first procedure. In other words, if you had vertebroplasty performed without the Cavity Spine Wand, that same procedure would be performed for the second bone. The procedure would only be repeated this 1 additional time, and not a third time.

No matter which treatment you receive, the entire procedure should take about 2-3 hours. If you need to have the procedure repeated on a second broken bone, this additional procedure should add about 45 minutes to the 2-3 hours that the first procedure alone would have taken.

Blood Testing for Phase 1 Participants:

Phase 1 participants will have blood (about 1 tablespoon each time) drawn at 8 different times points in order to measure the number of tumor cells. This blood will be drawn at 10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery.

Blood Testing for Phase 2 Participants:

Phase 2 participants will have blood (about 1 tablespoon each time) drawn at 4 different time points after surgery. The first and second blood draw will occur before 36 hours has passed. The third blood draw will be about 36 hours after the surgery, and the fourth blood draw will be about 7 days after the surgery. This blood will be tested to measure the number of tumor cells.

Follow-Up Care:

You will be asked to return for follow-up visits at 7 days after your surgery and again at 4 weeks after your surgery. At these visits, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of vital signs.
* You will complete the questionnaires that ask about the back pain and any drugs you are taking.
* You will be asked to walk a 50-foot distance, and your walk will be timed.
* At the Day 7 visit only, blood (about 1 tablespoon) will be drawn to measure the number of tumor cells.
* At the Week 4 visit only, you will be asked to complete a questionnaire that asks you to rate how satisfied you feel with the surgery. It should take about 10 minutes to complete.

At 3 months after your surgery, the study staff will call you at home to ask about the back pain and any drugs you may be taking.

Length of Study Participation:

After the Month 3 follow-up phone call, your active participation in this study will be over. If it is determined after your surgery that the tumor in your back was not cancerous, you would still return for the follow-up visits as is standard, but you would not need to have the Day 7 blood test to measure the number of tumor cells.

This is an investigational study. The vertebroplasty and kyphoplasty procedures are commercially available and FDA approved for the way they are being used in this study. The Cavity SpineWand is also commercially available and FDA approved for the way it is being used in this study. The research-specific part of this study is the blood testing to measure any increases in the number of cancer cells in the blood.

Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

Anderson Circulating Tumor Cell Burden (CTCB) Study

Assessment of Circulating Tumor Cell Burden After Radiofrequency-Based Plasma Ablation (COBLATION®) in Conjunction With Vertebroplasty or Kyphoplasty for Augmenting Painful Vertebral Compression Fractures Secondary to Malignancy

Increase in number of cancer cells in patient's blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).

ArthroCare Corporation

M.D. Anderson Cancer Center

No patients were enrolled in other groups or Phase II.

Phase 1 Group 1 Vertebroplasty

Phase 1 Group 2 Kyphoplasty

Phase 2 Group 1 Vertebroplasty

Phase 2 Group 2 Vertebroplasty +Cavity SpineWand

Phase 2 Group 3 Kyphoplasty

Phase 2 Group 4 Kyphoplasty + Cavity SpineWand

Total

Age, Continuous

United States

Region of Enrollment

Dawid Schellingerhout, MD/Asst. Professor

Study terminated by sponsor; No data analysis done on limited amount of data gathered.

Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)

Phase 2: Change in CTCB From Baseline to Post-treatment

Nervous System Diseases

Rare Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Neuroepithelioma

Antineoplastic Agents

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Etoposide

Etoposide phosphate

Valproic Acid

Enzyme Inhibitors

Neurotransmitter Agents

Valproate Starting Dose of 10 mg/kg By Mouth Daily. Etoposide 25 - 50 mg/m\^2 By Mouth Daily.

Valproate

Tribhawan S Vats, MD

Primary Objective:

* Determine the interindividual range and median of individual maximum tolerated doses of valproic acid administered as one time evening dose in conjunction with a dose oral etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four different age groups.

Secondary Objectives:

* Determine the qualitative and quantitative toxicity and reversibility of toxicity of valproic acid in conjunction with oral etoposide,
* To investigate the clinical pharmacokinetics of valproic acid when given in conjunction with oral etoposide,
* To describe quality of life of patients with relapsed, or progressive central and peripheral nervous system tumors when treated with oral valproic acid and etoposide,
* To observe and describe the response pattern of progressive central nervous system tumors treated with oral valproic acid and etoposide,
* To observe and describe event free survival time and overall survival time of patients with relapsed, or progressive central nervous system tumors when treated with oral valproic acid and etoposide,
* To determine if histone deacetylase activity and topoisomerase expression in lymphocytes of patients is related to valproic acid levels, and
* To determine, if the individual maximal tolerated dose (iMTD) depends on the initial performance status of the patient in the beginning of the treatment.

Study Drugs:

Etoposide is designed to block cell growth by breaking the DNA, which may cause the cells to die.

Valproic acid was first designed as an anti-seizure medication. It was also found to change cancer cells and make them more sensitive to etoposide.

Screening Tests:

Before you start treatment on this study, you will have "screening tests". These tests help your doctor decide if you are eligible to take part in this study.

* Your medical history will be reviewed.
* You will have a physical exam.
* You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
* You will complete a questionnaire about your activities or daily living. The questionnaire will take about 5 to 10 minutes to complete.
* Blood (about 2-3 tablespoons) will be drawn for routine tests. This routine blood draw may include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
* Urine may be collected to check for metabolic disease. This urine sample may include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
* You will have a magnetic resonance imaging (MRI) or computed tomography (CT) scan.
* If your doctor thinks it is necessary, you may have additional blood and/or urine tests.

Dose Escalation:

When you begin the study, you will begin receiving the lowest dose level of valproic acid. Every week, the dose will be increased. This will continue until the maximum tolerated dose (MTD) is found. Once the MTD is found, you will continue to receive that dose level of valproic acid while you are on study. However, if your doctor thinks it is necessary, this dose level could be lowered.

If you are a child (less than or equal to 18 years of age), the amount of etoposide that you take while on study will not change.

If you are an adult (more than 18 years of age), your will receive a low dose of etoposide while the MTD of valproic acid is being found. After the MTD of valproic acid is found, your dose of etoposide will be increased every week until the MTD is found. However, if your doctor thinks it is necessary, this dose level could be lowered.

Study Drug Administration:

You will receive valproic acid and etoposide every evening in pill form.

If you have difficulty swallowing the pills, etoposide can be given in the evening in liquid form. Valproic acid can be given in liquid form, divided in 2 doses per day, 1 in the morning and 1 in the evening.

Study Visits During Dose Escalation:

While your valproic acid or etoposide medication is being increased, every week you will have a physical exam and blood (about 2-3 tablespoons)and urine will be collected for routine tests.

Every other month, you will have CT or MRI scans to check the status of the disease. You may have these tests and procedures more often if your doctor thinks it is necessary.

Study Visits After Maximum Tolerated Dose (MTD):

Every month, you will have a physical exam, and blood (about 2-3 tablespoons) and urine will be collected for routine tests.

Every other month, you will have CT or MRI scans to check the status of the disease.

Every 6 months, a portion of the blood or urine collected for routine tests will be used for a pregnancy test for women who are able to have children.

-You may have these tests and procedures more often if your doctor thinks it is necessary.

Length of Study:

You may remain on study for up to 2 years. You will be taken off study if the disease gets worse or intolerable side effects occur.

End-of-Study Visit:

Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 2-3 tablespoons) and urine will be collected for routine tests.
* If your doctor thinks it is necessary, you will have a CT or MRI to check the status of the disease.

Follow-Up:

Once you are off study, you will be contacted by telephone once a year to check the status of the disease. The phone call will take 2-3 minutes.

This is an investigational study. Etoposide is FDA approved and commercially available. Valproic acid is FDA approved and commercially available for the treatment of seizures. The use of these drugs together is investigational. Up to 120 patients will take part in this multicenter study. Up to 100 will be enrolled at M. D. Anderson.

Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases

Valproate (Valproic Acid) and Etoposide for Patients With Progressive, Relapsed or Refractory Neuronal Tumors and Brain Metastases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Spinal Radiosurgery	NCT00573872	Neoplasm Arteriovenous M...	Radiosurgery	19 Years -	University of Alabama at Birmingham
A Phase II Study of Spinal Radiosurgery	NCT00573872	Neoplasm Arteriovenous M...	Radiosurgery	19 Years -	University of Alabama at Birmingham
A Phase II Study of Spinal Radiosurgery	NCT00573872	Neoplasm Arteriovenous M...	Radiosurgery	19 Years -	University of Alabama at Birmingham
Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery	NCT00747292	Neoplasm Diverticular Di... Analgesia	epidural PCA Spinal	18 Years -	Minimal Access Therapy Training Unit
Anderson Circulating Tumor Cell Burden (CTCB) Study	NCT00819832	Cancer Spinal Disease Vertebral Compr...	Kyphoplasty Vertebroplasty Cavity SpineWan...	18 Years -	M.D. Anderson Cancer Center
Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases	NCT00513162	Neuroectodermal... Brain Metastase... Advanced Cancer	Valproate Etoposide	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for spinal

Every month we try and update this database with for spinal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for spinal

Every month we try and update this database with for spinal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for spinal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.