NCT02390739 — drugset

Summary

Background The NCI Surgery Branch has developed an experimental therapy for treating patient with metastatic thyroid cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-thyroglobulin incorporated in the retrovirus. Objectives: The purpose of this study is to see if these tumor fighting cells (genetically modified cells) that express the receptor for the thyroglobulin molecule on their surface can cause thyroid tumors to shrink and to see if this treatment is safe. Eligibility: \<TAB\>Adults 18 and older with thyroid cancer that has the thyroglobulin molecule on tumor surfaces Design: \<TAB\>Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed \<TAB\>Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti- thyroglobulin cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} \<TAB\>Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-thyroglobulin cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.

Timeline

Start: 2015-03-02
Primary completion: 2017-03-22
Completion: 2017-03-22

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anti-Thyroglobulin mTCR PBL	Unknown	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	60 mg/kg	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous
Background	aldesleukin	Protein / enzyme biologic	720000 iu/kg	Intravenous

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing Human Thyroglobulin to People With Thyroglobulin Expressing Thyroid Cancer

Summary

Timeline

Publications

Drugs

Indications