Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Endometriosis

Neurilemmoma

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neuroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Schwannoma

Neuroendocrine Tumor

Neuroepithelioma

Emilie FALLER, MD

Alexandre PIFFER, MD

Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.

Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.

Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.

How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma

The aim of this research is to train surgeons to perform laparoscopic removal of a retroperitoneal pelvic schwanoma

University Hospital, Strasbourg, France

Diseases and Abnormalities at or Before Birth

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Glioma

Meningioma

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Ependymoma

Neuroma, Acoustic

Neurofibromatosis 2

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Cranial Nerve Diseases

Neurofibromatosis

Neurofibromatosis Type 1

Acoustic Neuroma

Neurofibromatosis Type 2

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Lapatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Lapatinib PO dosed according to age:

Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily

Adults (18 years of age or older): 1,500 mg PO once daily

Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.

Lapatinib is dosed according to age. Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.

Children/adolescents (\<18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO (3 tablets twice daily)

Adults (\>=18 years of age): 1,500 mg PO (6 tablets once daily)

Duration: Up to 12 months, depending on treatment response.

Matthias A Karajannis, MD, MS

The purpose of this study is to determine if Lapatinib has any effect on tumors found in patients with Neurofibromatosis Type 2 (NF2). NF2 is a condition that mainly affects the skin and nervous system. It causes non-cancerous tumors (which are known as neuromas) to grow on the nerves around a person's body. Some signs of NF2 include a gradual loss of hearing and tumors growing on the skin, the brain and the spinal cord which can lead to complications.

Lapatinib is an oral drug that is approved by Food and Drug Administration (FDA) for other types of tumors, it is not approved by the FDA for treatment of NF2 related tumors. The investigators know a lot about how well it is tolerated, but the investigators do not know if it is effective in treating your condition, therefore it is considered to be an investigational medication. This study will test whether Lapatinib may shrink tumors commonly found in patients with NF2 or stop them from growing. This will help us to decide if Lapatinib should be used to treat NF2 patients in future. Lapatinib is a drug that has been used for over 10 years to treat various forms of cancer. It has not been studied for the treatment of tumors in NF2 patients.

In this trial, we propose to assess the objective response rates to Lapatinib in patients with NF2-related tumors. Lapatinib is a commercially available inhibitor of ErbB2 and EGF. Data suggests that abnormal signaling via EGFR and ErbB2 is a major contributor to tumor growth and progression in both sporadic and NF2-related VS and that inhibition of this signaling pathway can result in decreased tumor growth.

Demonstrating that Lapatinib produces an objective response to reduce tumor volume or stabilize disease will provide additional treatment options for NF patients with multiple tumor growth. For patients with VS we expect to see ≥ 10 dB improvement in PTA and/or improvement in SDS, compared to the audiogram at initiation of treatment. Currently there are no available treatment options for NF2 patients with multiple tumors. Depending on tumor cell type, lapatinib has cytostatic or cytotoxic antitumor effects, and in a recent study assessing the biological effects of Lapatinib on the associated molecular pathways and tumor growth in patients with solid tumors, a correlation was seen between tumor response and pre-treatment levels of (phosphor)-ErbB2 and (phosphor)-ERK1/2.

Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

Phase II Study of Lapatinib in Children and Adults With Neurofibromatosis Type 2(NF2) and NF2-related Tumors

Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of volumetric progression. PFS was analyzed using the Kaplan-Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.

Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan-Meier curves.

Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of hearing progression. PFS was analyzed using the Kaplan-Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.

Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan-Meier curves.

Toxicity was assessed throughout the study, up to one year.

GlaxoSmithKline

NYU Langone Health

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Matthias Karajannis, MD

This analysis is based on the 17 evaluable patients.

Estimated Volumetric Progression Free Survival at 12 Months

Estimated Volumetric Progression Free Survival for Hearing at 12 Months

Participants Experiencing Grades 1 or 2 Toxicities (CTCAE)

Participants Experiencing Grade 3 Toxicities (CTCAE)

Overall Study

Chronic Pain

Pain

Skin Neoplasms

Neurologic Manifestations

Skin Diseases

Chronic Graft Versus Host Disease

Schwannomatosis

Analgesics

Bone Density Conservation Agents

Vasodilator Agents

Antibodies

Antibodies, Monoclonal

Erenumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Siltuximab

Calcitonin

Salmon calcitonin

Calcitonin Gene-Related Peptide

Katacalcin

Immunologic Factors

The treatment period includes a double-blind treatment period (days 1-84) and an open-label treatment period (days 85-168).

All participants will receive siltuximab during this drug sub-study. Twenty (20) participants will be randomized to receive either Siltuximab or matching placebo during the double-blind treatment period. All participants will receive siltuximab during the open-label treatment period. Participants will complete study procedures as outlined:

* Double-Blind Treatment period: Administration of Siltuximab versus matching placebo in pre-determined dose once every 21 days (for 4 cycles).
* Open-Label Treatment period: Administration of Siltuximab in pre-determined dose once every 21 days (for 4 cycles).

The treatment period includes a single-blind treatment period (days 1-84) and an open-label treatment period (days 85-168).

All participants will receive erenumab-aooe during this drug sub-study. Twenty (20) participants will receive a randomization assignment to receive either Erenumab-Aooe or matching placebo during the single-blind treatment period. All participants will receive erenumab-aooe during the open-label treatment period. Participants will complete study procedures as outlined:

* Single-Blind treatment period (days 1 - 84): Administration of Erenumab-Aooe versus matching placebo in pre-determined dose once every 28 days (for 3 cycles).
* Open-Label Treatment period (days 85-168): Administration of Erenumab-Aooe in pre-determined dose once every 28 days (for 3 cycles).

A chimeric immunoglobulin G mAb, via intravenous infusion.

Human monoclonal antibody, single-dose prefilled SureClick® autoinjector, via subcutaneous injection.

Erenumab-Aooe

Dextrose 5% in water, via intravenous infusion.

Siltuximab Matching Placebo

0.9% saline, 1 mL single-dose prefilled syringe, via subcutaneous injection.

Erenumab-Aooe Matching Placebo

Scott Plotkin, MD, PhD

Lei Xu, PhD

Lauren Hibyan, RN

Marie Aste, RN

Scott Plotkin, MD

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).

This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies:

* Investigational Drug Sub-Study A: Siltuximab
* Investigation Drug Sub-Study B: Erenumab-Aooe

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).

The MASTER STUDY has no study drug or intervention. It is intended to enroll participants who will be placed into different treatment arms (SUB-STUDIES), which will each have an additional consent and enrollment process.

MASTER STUDY

* The research study procedures include screening for eligibility, randomization to an experimental treatment sub-study, if qualified, and observation for up to 10 years.

  * Subjects who complete treatment on one experimental arm will be permitted to enroll in a different experimental treatment arm if they meet eligibility criteria.
  * Participants who are not eligible for enrollment in a different treatment sub-study will be permitted to remain under observation on this Master Study to understand the natural history of schwannomatosis-related pain and tumor growth pattern.
  * Participants will be eligible to remain on this Master Study for up to 10 years.
  * It is expected that about 40 people will take part in the Master Study.
  * The study will randomize a maximum of 20 participants to each of the experimental arms. The overall size of the trial is not fixed by design because it includes arm-dropping rules for futility and allow for the possibility of arm addition by amendment.
* Upon meeting Master Study qualifications, participant will be randomly assigned to a treatment sub-study.

SUB-STUDY A - SILTUXIMAB

* The purpose of this study is to find out what effects, good and/or bad, siltuximab has on schwannomatosis-associated pain.
* The U.S. Food and Drug Administration (FDA) has not approved Siltuximab for schwannomatosis but it has been approved for the treatment of people with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
* Siltuximab was identified as a potential treatment for schwannomatosis tumors in a screen of compounds in a laboratory. Siltuximab is believed to work by blocking the growth signals and inflammation in tumor cells.
* Upon meeting sub-study qualifications, participant will be randomly assigned to either the early-start group or the delayed-start group.
* Twenty (20) people will take part in the siltuximab Sub-study.
* Participants in the early-start group will receive siltuximab every 3 weeks over 168 days. Participants in the delayed-start group will receive placebo every 3 weeks for the first 84 days followed by siltuximab every 3 weeks over the subsequent 84 days (for a total of 168 days).

SUB-STUDY B - ERENUMAB-AOOE

* The purpose of this study is to find out what effects, good and/or bad, erenumabaooe has on schwannomatosis-associated pain.
* The U.S. Food and Drug Administration (FDA) has not approved Erenumab-Aooe for schwannomatosis but has approved it for treatment of migraines headaches in adults.
* Erenumab-Aooe was identified as a potential treatment for schwannomatosis pain. Erenumab-aooe acts by blocking pain signals in the body. By blocking pain signals, erenumabaooe may reduce pain associated with schwannomatosis.
* Upon meeting sub-study qualifications, participant will be randomly assigned to either the early-start group or the delayed-start group.
* Twenty (20) people will take part in the ERENUMAB-AOOE Sub-study.
* Participants in the early-start group will receive erenumab-aooe every 4 weeks over 168 days. Participants in the delayed-start group will receive placebo every 4 weeks for the first 84 days followed by erenumab-aooe every 4 weeks over the subsequent 84 days (for a total of 168 days).

(1) Double-Blind period for Siltuximab or Placebo Arm; and (2) Single-Blind period for Erenumab-Aooe or Placebo Arm

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Defined as the change in the worst pain intensity between baseline and day 85. Worst pain is measured using the 11-point Pain Intensity Numerical Rating Scale (NRS), where scores range from 0 (no pain) to 10 (worst pain ever) of the maximum SWN-related pain experienced over the past week

Graded according to NCI CTCAE v5.0. All participants will be evaluable for toxicity from the time of first treatment.

United States Department of Defense

Recordati Rare Diseases

Massachusetts General Hospital

Principal Investigator

Glutamic Acid

A bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL

18F-DCFPyL Injection

Steven Rowe, M.D., Ph.D

To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.

The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, \[18F\]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.

Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

The primary objective of this project is to test the feasibility of 18F-DCFPyL to detect cancer. The visual assessment of suspected tumor will be considered positive if there is sustained radiotracer activity over expected soft tissue or blood pool physiologic activity levels and recorded as mild (above blood pool), moderate (above blood pool, but less than liver), or intense (at or above the liver). Feasibility will be determined based on number of positively recognized regions of interest.

National Cancer Institute (NCI)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma	NCT06313411	Endometriosis P...		18 Years -	University Hospital, Strasbourg, France
Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	NCT00973739	Neurofibromatos... Vestibular Schw...	Lapatinib	4 Years - 80 Years	NYU Langone Health
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)	NCT05684692	Schwannomatosis Schwannomas Pain, Chronic	Siltuximab Erenumab-Aooe Siltuximab Matc... Erenumab-Aooe M...	18 Years -	Massachusetts General Hospital
Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET	NCT03542773	Schwannomas Malignant Tumor...	18F-DCFPyL Inje...	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	NCT00973739	Neurofibromatos... Vestibular Schw...	Lapatinib	4 Years - 80 Years	NYU Langone Health
Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	NCT00973739	Neurofibromatos... Vestibular Schw...	Lapatinib	4 Years - 80 Years	NYU Langone Health

Spots Global Cancer Trial Database for schwannomas

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

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