Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

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

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Pembrolizumab

Prednisolone

Immunomodulating Agents

Nivolumab

Ipilimumab

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Trametinib

Dabrafenib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Intravenous infusion of pembrolizumab 2 mg/kg every third week for up to two years.

Intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years.

Induction treatment with BRAF/MEK inhibitors (either the combination of encorafenib/binimetinib or dabrafenib/trametinib) orally for 28 days followed by intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years.

Pembrolizumab Injection [Keytruda]

Ipilimumab Injection [Yervoy]

Nivolumab Injection [Opdivo]

Encorafenib

Binimetinib

Inge M Svane, Professor

Troels H Borch, PhD

Marco Donia, PhD

Henrik Schmidt, PhD

Lars Bastholt

This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).

Cancer immunotherapy with checkpoint inhibitors (CPI) has demonstrated significant response rates, with clinical responses of exceptional duration observed in pivotal clinical trials for multiple types of solid tumors. Results from clinical trials demonstrate a considerable survival benefit of CPI over standard treatments, leading to registration of CPI for lung-, head and neck-, bladder-, renal cancer, lymphomas and metastatic melanoma (MM). To date, CPI appear to hold the key for longterm survival - at least for patients treated in clinical trials.

Patients enrolled in pivotal clinical trials for immunotherapy of MM are highly selected and does not include patients with brain metastases. Small phase II studies lend support to CPI to yield responses in melanoma that has metastasized to the brain. However, a large proportion of patients that develop brain metastasis will require continued systemic treatment with steroids to alleviate symptoms from the central nervous system (CNS). This group of patients are not offered treatment with CPI, as it is generally assumed that steroid treatment hamper their clinical efficacy. Thus, this group of patients face a large unmet need.

Due to the immune inhibiting effects, steroids are used to manage immune-related adverse events (irAEs) induced by CPI treatment. However, patients receiving steroids in this context are still able to achieve and maintain clinical benefit even after stopping treatment.

It is not known whether steroid treatment at the time of initiation of CPI treatment diminishes the treatment effect, as patients in need of steroid treatment are generally excluded from clinical trials.

Six patients are enrolled in each arm. If clinical benefit is observed, each arm will be expanded to enroll a total of 20 patients.

Melanoma Metastasized to the Brain and Steroids

Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids

Proportion of patients who did not progress or die within 6 months from commencing study treatment.

Proportion of patients who did not die within 6 months from commencing study treatment.

Time from commencing study treatment to the date of progression or death.

Time from commencing study treatment to the date of death from any cause.

Proportion of patients with an overall complete or partial response according to modified RECIST 1.1.

Proportion of patients with an overall complete or partial response in extracranial lesions according to modified RECIST 1.1.

Proportion of patients with an overall complete or partial response in intracranial lesions according to modified RECIST 1.1.

Proportion of patients with an overall complete, partial response or stable disease \> 6 months according to modified RECIST 1.1.

Correlation of the baseline PD-L1 status, immune markers, genomics and other biomarkers in tumour tissue and blood with complete or partial response and at subsequent disease progressionanalyses of potential specific biomarkers predictive of response or progression.

Inge Marie Svane

Professor, MD, PhD

Hemangioma

Neoplasms, Vascular Tissue

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Propranolol

Adrenergic beta-Antagonists

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Kyung-Duk Park, MD, Ph D

Tae Hyun Choi, MD, Ph D

The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

* Randomized (A group : propranolol, B group : prednisolone)
* A group : 3 days admission and medication for 16 weeks
* B group : medication for 16 weeks without admission
* Hemangioma volume comparison by using MRI
* other measurement and drug adverse reaction monitoring

The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction.

Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))

Number of Participants in which, the Heart rate fell to \<70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to \<70% of acceptable age related minimum post-dose with child awake

Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color

size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)

Number of participants with Reepithelialzation in 16weeks..

Number of participants whose hemangioma stop proliferating in 16weeks

Number of participants whose hemangioma showed regression in 16 weeks.

We checked Number of participants with Drug compliance within 16 weeks

Number of Participants in Which, the Systolic blood pressure fall of \>25% of baseline postdose with child awake, Anytime During the 16 Weeks..

Number of Participants in Which, Glucose levels fall (to \<50mg/dl), Anytime During the 16 Weeks..

Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..

Number of Participants with Growth Retardation within 16 weeks..

Number of Participants With Gastroesophageal reflux within 16 weeks..

All symptoms associated adverse drug reaction will be checked

Seoul National University Hospital

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

South Korea

Region of Enrollment

Hemangioma volume by MRI

Although the sample size in the present study was predetermined to show noninferiority, it is difficult to provide strong evidence of safety outcomes.

The present study was not a double-blind trial.

Prof. Tae Hyun Choi

Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO

Percent Reduction in Hemangioma Volume From Baseline

Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks

Purple

Number of Participants With Change in Color as Compared to Baseline

Number of Participants With Size Reduction of Ulceration

Number of Participants With Reepithelialzation in 16weeks

Number of Participants With Stop of Proliferation

Number of Participants With Regression

Number of Participants With Drug Compliance Within 16 Weeks

Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks

Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks

Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks

Number of Participants With Growth Retardation Within 16 Weeks

Number of Participants With Gastroesophageal Reflux Within 16 Weeks

Number of Participants With Adverse Drug Reaction

Overall Study

Musculoskeletal Diseases

Nervous System Diseases

Neuroma

Morton Neuroma

Nerve Sheath Neoplasms

Metatarsalgia

Foot Diseases

Joint Diseases

Neuralgia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Pain

Neurologic Manifestations

Channel Blockers

Central Nervous System Depressants

Anti-Infective Agents

Lidocaine

Ethanol

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Injection of Steroid into Foot

Injection of Alcohol into Foot

Injection of Lidocaine into Foot

Mark C Lee, MD

Christopher Digiovanni, MD

Interdigital neuroma is a painful forefoot disorder characterized by plantar pain and toe paresthesias thought to result from entrapment of the interdigital nerve by the overlying transverse metatarsal ligament. Multiple treatments have been recommended for this condition and range from modification of shoe wear to surgical excision of the painful nerve. Serial ethanol injection therapy has been reported to be an effective alternative to surgical excision. However, despite wide adoption of this treatment, no randomized, double blinded, placebo-controlled study exists to verify the efficacy of this treatment in comparison to longer standing similar therapies, such as corticosteroid injection.

120 patients from one Orthopaedic group's foot and ankle offices with single foot neuromas and no previous history of neuroma or foot disorder treatment will be selected for the study. These patients will be randomized to three treatments, specifically lidocaine injection, corticosteroid injection, or ethanol injection. Outcomes will be assessed at 3, 6 and 12 month time points using validated questionnaires as well as a non-validated disease specific questionnaire. Primary endpoint will be graded change in the physical function portion of the SF-36 form. Secondary endpoints will be the graded change in the McGill Short Form for Pain and ultimate satisfaction with treatment as assessed by a non-validated questionnaire designed for Morton's neuroma symptoms.

Interdigital neuroma, or Morton's Neuroma, is a painful forefoot disorder characterized by plantar pain and paresthesias radiating to toes. The condition was first described in 1845 by Lewis Durlacher as a painful "neuralgic affection" of the plantar nerve between the third and fourth metatarsals. T.G. Morton, in 1876, attributed the painful symptom complex to a "neuroma." His observation was confirmed by Hoadley who, in 1893, performed a curative excision of a "neuroma" between the third and fourth metatarsals.

Current understanding of interdigital neuroma is based on Gauthier's conclusion in 1979 that the symptom complex was a result of an entrapment neuropathy of the interdigital nerve by the overlying transverse metatarsal ligament. Presently, no definitive single etiology has been confirmed. Additional potential pathoetiologies include the aberrant anatomy of the plantar nerve in this location, trauma and extrinsic mass effect above or below the level of the transverse metatarsal ligament.(3,6) The histological appearance of the affected nerve, however, is consistent and suggests that "neuroma" is a misnomer for this condition. The nerve tissue demonstrates demyelination and deposition of amorphous eosinophilic material, but no exuberant proliferation of nerve endings characteristic of neuroma.(3)

Multiple treatments have been recommended for the management of interdigital neuroma. The usual algorithm begins with an attempt at conservative therapy consisting of shoe wear modifications and the application of a metatarsal pad. Failure of conservative management may prompt a trial of corticosteroid injections.(8) Persistent symptoms ultimately require surgical excision or division of the transverse metatarsal ligament, both of which have good long term outcomes in literature.(2,7)

Recently, serial ethanol injection therapy has been reported to be an effective alternative to surgical excision and has been widely adopted in the treatment of Morton's neuroma. Dockery et. al. reported 89% success rate in a series of 100 consecutive patients treated with 3 to 7 injections of 4% ethanol solutions with an average follow-up of 13 months. Fanucci and Masala reported a 90% success rate at 10 month follow-up after 3 to 7 injections of 30% alcohol in a consecutive series of 40 patients. However, none of these studies were performed in a randomized, double blinded fashion with adequate controls. Therefore, no scientifically valid conclusions concerning treatment efficacy can be made.

The proposed study investigates alcohol sclerosing therapy for the treatment of Morton's neuroma in a randomized, double-blinded, placebo-controlled clinical trial. The primary end point will be evaluation of patient physical function according to the standardized SF-36 questionnaire after the treatment period. Secondary end points include evaluation of pain and satisfaction levels after treatment using, respectively, a standardized and a novel questionnaire.

Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma

Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Morton's Neuroma

Brown University

Pain, Postoperative

Breast Neoplasms

Syndrome

Postoperative Complications

Nausea

Vomiting

Systemic Inflammatory Response Syndrome

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Inflammation

Shock

Dexamethasone

Dexamethasone acetate

Kristin J Steinthorsdottir, MD

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after breast cancer surgery, with removal of the breast (mastectomy). Primary outcome is the proportion patients who require transfer to the post anaesthesia care unit (PACU) and the proportion that can be transferred directly to the ward. Secondary outcomes are organospecific complications in the postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery.

The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.

The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.

Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.

Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.

Based on positive results in other procedure-specific studies, all mastectomy patients at Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg dexamethasone injection since mid-2015. This has resulted in a decrease in the proportion of patients who need observation in PACU from 30 % to 10 %. The reduction is primarily due to less pain, less sedation, and lower opioid administration.

Whether this is also partly due to a "systemic effect" (Hawthorn effect) as a result of increased focus on the area cannot be excluded.

Prior to creating clinical recommendations and standards, it is required that the results be tested in a randomized, controlled, clinical trial.

The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV have been shown in numerous trials, and is already being administered to all patients at the clinic. It would therefore not be ethically correct to withdraw from this practise.

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial

Number of patients meeting criteria for transfer to PACU post-surgery

Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM) discharge score.Construct: The score consists of six modalities (subscores): Sedation,Oxygen saturation,blood pressure,heart rate,pain (at rest)and nausea.Each modality has a score between 0 and 3,and patients are considered dischargeable to the ward when the score sum of all criteria (total score) is 4 or less and no single score is above 1. All values (subscores) are considered best at 0 and worst at 3.

Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping aroused by physical stimuli, 3 sleeping cannot be aroused.

Oxygen saturation (%):0 ≥94, 1 90-93, 2 85-89, 3 \<85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or \>220, 3\<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 \<40 or \>130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting.

DASAIM score (Danish Society of Anesthesiology and Intensive Care Medicine). The score consists of six modalities: Sedation, Oxygen saturation, blood pressure, heart rate, pain (at rest) and nausea.

Each modality has a score between 0 and 3, and patients are considered dischargeable to the ward when the score sum of all criteria is four or less and no single score is above one.

Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping, aroused by physical stimuli, 3 sleeping, cannot be aroused.

Oxygen saturation (%): 0 ≥ 94, 1 90-93, 2 85-89, 3 \<85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or \>220, 3\<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 \<40 or \>130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting.

complications requiring treatment until discharge

Length of stay in the post-anesthesia care unit (PACU), measured as hours and minutes, from start of procedure, to discharge from PACU

Length of stay in hospital, measured from start of procedure to discharge from hospital to home

Secondary transfer to PACU from ward, or to intensive care unit from PACU

Self-reported pain (worst and average (average through that day), days 0-4) on a numeric rating scale (NRS) 0-10. 0 is no pain, 10 is worst pain imaginable.. Questionnaire.

Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting

Self-reported quality of sleep (days 0-4). Questionnaire. Dichotomized to Good sleep or sleep problems, numbers reported are number of patients with sleep problems

Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes)

Seroma, requiring treatment the first 14 days.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Melanoma Metastasized to the Brain and Steroids	NCT03563729	Malignant Melan...	Pembrolizumab I... Ipilimumab Inje... Nivolumab Injec... Encorafenib Binimetinib Dabrafenib Trametinib	18 Years -	Herlev Hospital
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma	NCT01908972	Hemangioma	Prednisolone Propranolol	- 9 Months	Seoul National University Hospital
Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma	NCT00284583	Morton's Neurom...	Injection of St... Injection of Al... Injection of Li...	18 Years - 60 Years	Brown University
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy	NCT03125941	Dexamethasone Glucocorticoids Mastectomy Breast Cancer Pain, Postopera... Nausea and Vomi... Steroid Systemic Inflam... Postoperative C...	Dexamethasone	18 Years -	Rigshospitalet, Denmark
Melanoma Metastasized to the Brain and Steroids	NCT03563729	Malignant Melan...	Pembrolizumab I... Ipilimumab Inje... Nivolumab Injec... Encorafenib Binimetinib Dabrafenib Trametinib	18 Years -	Herlev Hospital
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma	NCT01908972	Hemangioma	Prednisolone Propranolol	- 9 Months	Seoul National University Hospital
Melanoma Metastasized to the Brain and Steroids	NCT03563729	Malignant Melan...	Pembrolizumab I... Ipilimumab Inje... Nivolumab Injec... Encorafenib Binimetinib Dabrafenib Trametinib	18 Years -	Herlev Hospital

Spots Global Cancer Trial Database for steroid

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

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