Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Farletuzumab

Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.

Bruce Wallin, MD

Nelson Oyesiku, MD, PhD, FACS

The purpose of this study is to evaluate whether therapy with farletuzumab is effective and safe in the treatment of resectable, non-functioning pituitary adenomas.

Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are \> 1 cm in size that can cause progressive visual loss, headaches, and symptoms of pituitary dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete surgical resection of the tumor, repeat surgery and external beam radiation therapy may be performed. Previous clinical work suggests there may be a role for a folate receptor in the treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against resectable, non-functioning pituitary adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to determine if therapy with farletuzumab is effective and safe.

Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas

Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma

Morphotek

Musculoskeletal Diseases

Rare Diseases

Acromegaly

Bone Diseases

Bone Diseases, Endocrine

Somatostatin

Philippe BALTZINGER, MD

Saïd CHAYER, PhD, HDR

Ninon STAHL, MD

At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described.

Thus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.

Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

University Hospital, Strasbourg, France

Neuroendocrine Tumors

Neuroendocrine Tumor

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

IV-administration of 4.5 mg of the fluorescent tracer bevacizumab-800CW to 3 patients with a pituitary neuroendocrine tumor (PitNET) with a Knosp grade of 3 or 4. The optimal dose will be expanded to include 6 patients.

IV-administration of 10 mg of the fluorescent tracer bevacizumab-800CW to 3 patients with a pituitary neuroendocrine tumor (PitNET) with a Knosp grade of 3 or 4. The optimal dose will be expanded to include 6 patients.

IV-administration of 25 mg of the fluorescent tracer bevacizumab-800CW to 3 patients with a pituitary neuroendocrine tumor (PitNET) with a Knosp grade of 3 or 4. The optimal dose will be expanded to include 6 patients.

Intravenous administration of 4.5, 10 or 25 mg of Bevacizumab-IRDye800CW prior to endoscopic transsphenoidal surgery

Bevacizumab-IRDye800CW

A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the Surgvision explorer endoscope. During surgery, three imaging moments are defined in which the fluorescence molecular endoscopy system will detect the fluorescent signal

Molecular Fluorescence Endoscopy platform

There is a need for improved visualization of presence and extent of pituitary neuroendocrine tumor (PitNET) tissue during transsphenoidal surgery (TSS), especially in tumors invading the cavernous sinus (CS). Optical molecular imaging of PitNET associated biomarkers is a promising technique to accommodate this need. Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in PitNET tissue compared to normal pituitary tissue and has proven to be a valid target for molecular imaging. Bevacizumab is an antibody that binds VEGF-A. By conjugating a fluorescent dye to this antibody, the fluorescent tracer molecule bevacizumab-800CW is created, which binds to VEGF-A. The investigators hypothesize that bevacizumab-800CW accumulates in PitNET tissue, enabling visualization using a molecular fluorescence endoscopy system. In this pilot intervention study the investigators will determine the feasibility of using microdoses (4.5, 10 and 25 mg) of bevacizumab-800CW to detect PitNET tissue intraoperatively.

The study is a non-randomized, non-blinded, prospective, single center, pilot dose-finding study.

Detection of PitNET Tissue During TSS Using Bevacizumab-800CW

Detection of Pituitary Neuroendocrine Tumor (PitNET) Tissue During Endoscopic Transsphenoidal Surgery Using Bevacizumab-800CW

To determine the sensitivity of the marker bevacizumab-800CW in discriminating between tumorous and non-tumorous tissue during endoscopic transsphenoidal surgery of pituitary neuroendocrine tumors (PitNETs) defined as the tumor to background ratio and intrinsic fluorescence

Data collection as a measure of safety and tolerability regarding administration of bevacizumab-800CW

Correlate the H/E images to the fluorescent images made with multiple ex vivo imaging modalities

Multi-diameter single-fiber reflectance with single-fiber fluorescence (MDSFR/SFF) spectroscopy can measure the fluorescence signal quantitatively, both in vivo and ex vivo

Imaging of the distribution of bevacizumab-800CW with a fluorescence microscope

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas	NCT01203618	Resectable, Non...	Farletuzumab	18 Years -	Morphotek
Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery	NCT05149495	Acromegaly		18 Years -	University Hospital, Strasbourg, France
Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery	NCT05149495	Acromegaly		18 Years -	University Hospital, Strasbourg, France
Detection of PitNET Tissue During TSS Using Bevacizumab-800CW	NCT04212793	Pituitary Tumor Pituitary Adeno... Pituitary Macro...	Bevacizumab-IRD... Molecular Fluor...	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for pituitary macroadenoma