Gland and Hormone Related Diseases

All Conditions

Neoplasms

Rare Diseases

Thyroid Diseases

Thyroid Neoplasms

Thyroid Carcinoma, Anaplastic

Carcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Thyroid Cancer, Medullary

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

sorafenib

Marcia S Brose, MD PhD

The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.

Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer

Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

This is the result of the Kaplan Meier analysis of all patients treated with sorafenib

University of Pennsylvania

Associate Professor

This is a single arm study.

sorafenib: 400mg PO BID daily

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

DIfferentiated

Poorly Differentiated

Medullary

Anaplastic

Histology subtype

ECOG Performance Status 0

ECOG Performance Status 1

Eastern Cooperative Oncology Group (ECOG) performance status is a well known classification system for patient performance status. The scale goes from 0 to 4. With 0 being fully active and functional and a 4 being 100% bedridden.

ECOG Performance Status at Baseline

Four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review.

Dr. Marcia Brose

Differentiated

Poorly Differenitated

Responses were calculated by total enrolled to each group by histologic subtype.

To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.

Progression Free Survival For Entire Study (55 Total Patients)

Of the 59 patients that were consented, four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review. Therefore the total number of patients analyzed going forward was 55.

Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib).

Overall Study

Symptoms and General Pathology

Recurrence

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antirheumatic Agents

Antibodies

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunoglobulins

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Intravenous infusion of lentiviral transduced autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity towards GFRa4 with fludarabine and cyclophosphamide.

single dose of CART-GFRa4 cells

Abramson Cancer Center Clinical Trials Service

Roger Cohen, MD

This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells expressing a single-chain scFv targeting GFRα4 with tandem TCR/CD3ζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART-GFRa4 cells") in patients with incurable medullary thyroid cancer (MTC).

The is a Phase I dose finding study to determine the safety of CART-GFRa4 cells. Dose escalation and determination of maximum tolerated dose (MTD) will be based on the standard 3+3 design to explore 3 possible dose levels.

GFRα4 CAR T Cells in MTC Patients

Phase I Trial of GFRα4 CAR T Cells in Adult Patients With Recurrent or Metastatic Medullary Thyroid Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
GFRα4 CAR T Cells in MTC Patients	NCT04877613	Metastatic Medu...	single dose of ... Fludarabine Cyclophosphamid...	18 Years -	University of Pennsylvania
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
GFRα4 CAR T Cells in MTC Patients	NCT04877613	Metastatic Medu...	single dose of ... Fludarabine Cyclophosphamid...	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for metastatic medullary thyroid cancer