Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Recurrence

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Oral Cancer

All Drugs and Chemicals

Sacituzumab govitecan

Immunoconjugates

Immunologic Factors

Paritcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion.

Sacituzumab Govitecan

Renata Ferrarotto, MD

To learn if sacituzumab govitecan can help to control salivary gland cancer.

Primary Objectives:

* To assess the efficacy of SG in patients with R/M secretory gland carcinomas, specifically ACC (cohort 1) and SDC, adeno-NOS, and MEC (cohort 2)

Secondary Objectives:

* To estimate the median duration of response (DOR)
* To estimate the median progression-free survival (PFS)
* To estimate the median overall survival (OS)
* To assess safety of SG

Tertiary / Exploratory Objectives:

* To explore biomarkers that may predict response to therapy

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

Gilead Sciences

M.D. Anderson Cancer Center

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients

neck dissection of at least the ipsilateral sub-level 1B

Thomas Robbins, M.D.

Hypothesis

1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it.
2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.

Study Design

A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.

Hypothesis

1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it.
2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.

Study Design

1. A prospective controlled study.
2. A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. In case of oral cavity tumors, about 15 minutes prior to the surgery, 1ml of Lymphazurin® blue dye will be injected in 4 quadrants around the primary site. The dissection will be performed in 3 stages. In the first stage all lymph node groups that lie either lateral, anterior, posterior, superior, or inferior to the submandibular gland, but within anatomical boundaries of level 1B, will be dissected. The submandibular gland will be left intact for this portion of the procedure. Next, the submandibular gland will be removed. Lastly, any remaining fibrofatty tissue that lies deep to the submandibular gland within the confines of level IB will be removed. Each lymph node group, the submandibular gland, and the fibrofatty tissue lying deep to the submandibular gland, will be submitted for pathological assessment in separate containers.
3. The following end-points will be measured: the number of lymph nodes identified within each lymph node group, the number of lymph nodes located within the submandibular gland, and the number of lymph nodes within the fibrofatty contents lying deep to the submandibular gland. The presence or absence of carcinoma within each of the assessed nodes will be documented, as well as extracapsular spread.

A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.

Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients

Prospective Study to Assess the Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Patients With Carcinoma of the Upper Aerodigestive Tract

The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.

Pathological detection of carcinoma within each of the dissected nodes reported as node groups.

Southern Illinois University

A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.

Surgery

Age, Continuous

<=18 years

Between 18 and 79 years

>=80 years

Age, Customized

Sex: Female, Male

Not completed

submandibular gland excision

sublevel IB dissection

surgical bed inspection

Director of Clinical Trials

Preglandular nodal group-Right neck

Prevascular nodal group-Right neck

Retrovascular nodal group-Right neck

Retroglandular nodal group-Right neck

Preglandular nodal group-Left neck

Prevascular nodal group-Left neck

Retrovascular nodal group-Left neck

Retroglandular nodal group-Left neck

Submandibular nodes (Right or Left)

Nodes Deep to Submandibular gland (Right or Left)

A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.

Surgical Lymph Node Groups

the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.

Preglandular nodal positivity right neck

Prevascular nodal positivity right neck

Retrovascular nodal positivity right neck

Retroglandular nodal positivity right neck

Preglandular nodal positivity left neck

Prevascular nodal positivity left neck

Retrovascular nodal positivity left neck

Retroglandular nodal positivity left neck

The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers	NCT05884320	Gland Salivary Gland ...	Sacituzumab Gov...	18 Years -	M.D. Anderson Cancer Center
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients	NCT00728130	Carcinoma	neck dissection...	18 Years -	Southern Illinois University

Spots Global Cancer Trial Database for gland

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

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