Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Hypopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Hypopharyngeal Cancer

Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Head and Neck Surgery using the da Vinci® Robotic System

da Vinci® Robotic System

William Carroll, MD

To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions

Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

University of Alabama at Birmingham

Professor of Surgery

TORS Candidates

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Number of participants with adequate exposure

Number of participants without adequate exposure

Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions

Known complication: oral hemorrhage

Known complication: injury to perioral structures

Known complication: airway edema

Known complication: nerve injury

Need for conversion to open procedure during surge

Need for re-exicision due to positive margins

Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System

Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.

Overall Study

Gland and Hormone Related Diseases

Endocrine Gland Neoplasms

Background:

* Tumors depend on blood vessels to provide the nourishment that allows them to grow.
* Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the tumors that contain the most blood vessels. Thus, endocrine tumors are important for the study of new blood vessel formation in tumors.

Objectives:

-To obtain tissues from endocrine tumors for examination to determine how they differ from normal tissue.

Eligibility:

-Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.

Design:

* Tissues will be obtained from patients during surgery to remove thyroid, parathyroid, adrenal, pancreas, or neuroendocrine tumors.
* About 400 patients will be enrolled in the study over a period of 5 years.

Background:

* Endocrine neoplasms are among the fastest growing tumors in incidence in the United States. Between 1995 and 2005, the incidence of thyroid carcinoma has increased 98 percent.
* Tumors of the thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among some of the most highly vascularized tumors seen.
* Consequently, endocrine neoplasms provide an extremely important model for the study of tumor angiogenesis.
* The Tumor Angiogenesis Section of the Surgery Branch, NCI has a focus on studying neovascular formation in neoplastic tissues. In addition, this section has primary responsibility for providing endocrine surgery consultative services to the NIH. As such, our Section is uniquely positioned to acquire and perform important studies on endocrine tissue to help advance our knowledge of the mechanisms involved in tumor vessel development. The majority of the patients enrolled on this study will be patients on other protocols throughout the NIH, for which our Section is consulted in order to perform their surgery.

Objectives:

Primary Objective:

-To develop a class predictor model based on gene expression patterns to distinguish benign from neoplastic endocrine tissue for each of the endocrine histologies under study. This objective will drive the statistical endpoints of the study.

Secondary Objectives:

* To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression changes, proteomic changes, and methylation changes.
* To perform histologic examination of these tissues including immunohistochemistry and in situ hybridization in order to study changes in tumor neovessel formation.
* To obtain, when accessible, adjacent normal endocrine tissue for comparison with the neoplastic tissue.
* To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal, pancreas, and extraadrenal neuroendocrine rests for future analysis and correlation with clinical outcome.

Eligibility:

* Patients with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms, including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine rests, paragangliomas, neuroblastomas and pancreas.
* Patients must have an ECOG performance score of 0-2.
* Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.

Design:

* A tissue acquisition trial in which tissues will be obtained at the time of surgical operation for the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas, paragangliomas and or extraadrenal rests of neuroendocrine tissue.
* Tissue will be processed at the time of collection, stored and then shipped to the PI's laboratory for further processing.
* No investigational therapy will be given.
* It is anticipated that 400 patients will be enrolled over a period of 5 years.

Evaluation of Blood Vessel Formation in Endocrine Tumors

Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Resiquimod

Immunomodulating Agents

Immunologic Factors

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week.

After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week.

After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.

1 ml of gp100 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.

gp100

Applied to the gp100 vaccine injection site immediately following the injection, allowed to air dry for 30 minutes then covered with gauze dressing.

R848 gel

1 ml of MAGE-3 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.

MAGE-3

Michael A. Davies, PHD

The goal of this clinical research study is to learn if the vaccines, gp100(g209-2M), and MAGE-3, when given in combination with resiquimod (R848), can help to stimulate the immune system against melanoma.

The Study Drug/Vaccines:

Resiquimod (R848) is designed to increase the production of antigen-specific T-cells, to activate immune cells, and to increase T-cells going into the tumor, which may cause the tumor cells to die.

gp100(g209-2M) and MAGE-3 are vaccines designed to stimulate immune cells, also called T-cells, which may help the immune system to recognize and kill melanoma cells.

Study Groups:

If you are found to be eligible to take part in this study, and you have metastatic melanoma, you will be assigned to Group 3. If you have had the melanoma removed and want to be treated to try to keep it from coming back, you will be randomly assigned (as in the flip of a coin) to Group 1 or 2.

* If you are in Group 1, you will receive the vaccines gp100(g209-2M) and MAGE-3 and R848 for 8 weeks. After 8 weeks, if you have melanoma lesions, you will apply R848 to half of the lesions on your body for 16 weeks.
* If you are in Group 2, you will receive only the vaccines (gp100(g209-2M) and MAGE-3) only for 8 weeks. After 8 weeks, if you have melanoma lesions, you will apply R848 to half of the lesions on your body for 16 weeks.
* If you are in Group 3, you will receive the vaccines gp100(g209-2M) and MAGE-3 and R848 for 8 weeks. After 8 weeks, if you have melanoma lesions, you will apply R848 to half of the lesions on your body for 16 weeks.

After 8 weeks, if you no longer have melanoma lesions, you will have completed the study treatment.

Study Drug/Vaccine Administration:

Once a week for 8 weeks, you will receive the vaccines, gp100(g209-2M) and MAGE-3, intradermally (through a needle into your skin) and subcutaneously (through a needle under your skin) at 2 separate sites in separate extremities. Half of each dose will be given one way, and half given the other way. These vaccines will also be given on the same day. You will receive a total of 4 injections each week.

If you are in Group 1, every time you have the vaccine injection, R848 will be applied as a gel over the gp100(g209-2M) injection site. The R848 gel will be allowed to air dry for 30 minutes and then covered with a gauze dressing which remain on overnight.

After 8 weeks, for participants with melanoma lesions, 2 times a week for 16 weeks, you will apply the R848 gel to half of the lesions on your body. You will be given written instructions and a "hands-on" demonstration on how to apply the gel. You will also be given a worksheet to help you with applying the gel.

Study Visits:

One day after your first dose of vaccine (Day 2), you will have a punch biopsy of the vaccine injection site to check your immune system. A punch biopsy is when a hollow instrument that is used to remove a small coin-shaped sample of tissue.

At Week 2, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* Blood (about 4 tablespoons) will be drawn to study your immune response to the vaccine combinations.
* You will have a punch biopsy of the injection site to check your immune system the day after the vaccine is given.

Every 4 weeks, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* Blood (about 4 tablespoons) will be drawn to study your immune response to the vaccine combinations.

Every 8 weeks, for participants with metastatic disease, the following tests and procedures will be performed:

* You will have CT or PET/CT scans of the chest, abdomen, and pelvis to check the status of the disease.
* The tumors will be measured and photographed. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are tumors on your face.
* If the doctor thinks it is necessary, the tumors will be measured by CT scan.
* If the doctor thinks it is needed, you will have an MRI/CT of the brain to check the status of the disease.

The day after you first start the gel (Week 8), you will have 2 punch tumor biopsies to check your immune system. One biopsy will be of a lesion with the R848 and one without, if it is available. For participants without disease, the study will be completed and your follow-up will be decided by your doctor.

At Week 0 (before vaccine is started), after treatment at Week 8 (+/- 1 week)., and Week 16 (+/- 1 week), white blood cells will be collected by leukapheresis to test for antibodies. If you have the leukapheresis, blood (about 2 teaspoons) will be drawn as well. If you do not have leukapheresis, blood (about 4 tablespoons) will be drawn instead.

The leukapheresis procedure is research-related and would not be performed as standard of care if you were not on study. Blood for the leukapheresis will be taken through a needle in a vein in one of your arms. A solution will be added to keep your blood from clotting while it goes through the machine that collects and removes white blood cells from your blood. The remaining blood is returned to you through a needle in a vein of your other arm. This is may take up to 3-4 hours. Although several pints of blood will go through the machine, only about 1/2 a pint (1 cup) will be in the machine at any time. If you cannot have a needle in your vein, this blood will be removed thorough a central venous catheter (CVC). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. You will be given another informed consent document to sign, which describes the risks of the CVC and the care involved.

Length of Study:

You will continue to receive treatment for up to 4 6 months, as long as you may benefit from the study and are responding to the gel. You will be taken off study if the disease gets worse or you experience any intolerable side effects. If you are in the group without disease, you will not receive the study treatment.

Follow-Up:

All three groups will be called 1 time a month for 12 months after coming off the study drugs to check on the status of the disease.

This is an investigational study. The study drugs/vaccines gp100(g209-2M), MAGE-3, and R848 are not FDA approved or commercially available. At this time, they are only being used in research.

Up to 71 participants will take part in this study. All will be enrolled at MD Anderson.

Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist

Activation of pDCs at the Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist

T-cell response to gp100(g209-2M) +/- MAGE3 measured at 8 weeks using a tetramer/multimer assay measured by flow cytometry. Based on the number of gp100(g209-2M) +/- MAGE3 T-cells measured, categorized as either immune responders or immune non-responders. T-cell response to the gp100(g209-2M) + /- MAGE3 peptide in each participant defined as ≥0.1% gp100(g209-2M) tetramer+ cells in the CD8+ T-cell population or ≥0.1% MAGE3 multimer cells in the CD4+ T-cell population.

Differences determined in each of these parameters between the pretreatment and post-treatment samples for each of the biopsied lesions for each participant.

M.D. Anderson Cancer Center

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.

Group 1: GP100 and MAGE-3 + R848

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.

Group 2: GP100 and MAGE-3

Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848

Total

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Michael Davis, PHD., Chair, Melanoma Medical Oncology

The original PI is no longer in the institution. Due to the absence of the original PI is no longer in the institution and the data is unavailable. The analysis for the primary outcome measure the comparison of immune responses of vaccine+R848 to vaccine alone is not available. All efforts were made to retrieve data.

Comparison of Immune Responses of Vaccine+R848 to Vaccine Alone

The original PI is no longer in the institution. Due to the absence of the original PI is no longer in the institution and the data is not available. The analysis for the secondary outcome measure the composite of Immune Cell Infiltration for pDCs, mDCs, and NK cells in Tumor Biopsy Samples data is unavailable .All efforts were made to retrieve data.

Composite of Immune Cell Infiltration for pDCs, mDCs, and NK Cells in Tumor Biopsy Samples

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

Propofol

Hypnotics and Sedatives

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study

BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

U Beese, Dr

The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.

Influence of Intracranial Lesions on Bispectral Index

"Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery	NCT00473564	Head and Neck C... Oropharyngeal C... Hypopharyngeal ... Upper Aerodiges...	da Vinci® Robot...	20 Years -	University of Alabama at Birmingham
Evaluation of Blood Vessel Formation in Endocrine Tumors	NCT00923780	Lesions		-	National Institutes of Health Clinical Center (CC)
Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist	NCT00960752	Melanoma	gp100 R848 gel MAGE-3	18 Years -	M.D. Anderson Cancer Center
Influence of Intracranial Lesions on Bispectral Index	NCT01060631	Supratentorial ...	BIS values at r... BIS values at r...	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for lesions

Every month we try and update this database with for lesions 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 lesions

Every month we try and update this database with for lesions 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 lesions 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.