NCT01943188

Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer

Pilot Study of Local Tumor Irradiation With Autologous T-Cell Infusion for Metastatic Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies the side effects and best way to give stereotactic body radiation therapy and T-cell infusion in treating patients with metastatic kidney cancer. Giving total body irradiation before a T-cell infusion stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. Chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the radiation therapy.

Detailed description

PRIMARY OBJECTIVES: I. Conduct a safety and feasibility study of stereotactic radiotherapy with autologous T-cell infusion for patients with metastatic renal cell carcinoma. SECONDARY OBJECTIVES: I. Determine the progression free survival at one year. II. Determine the overall survival at one year. OUTLINE: STEREOTACTIC BODY RADIATION THERAPY (SBRT): Patients undergo standard of care SBRT over 1-2 weeks according to tumor volume and location. LYMPHODEPLETION: Beginning 3 weeks later, patients receive cyclophosphamide orally (PO) twice daily (BID) for 3 days. REINFUSION OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC): Within 3-14 days of completing lymphodepletion with cyclophosphamide, patients undergo autologous PBMC infusion. After completion of study treatment, patients are followed up at 1 week, 4 weeks, and monthly thereafter.

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy	Undergo SBRT
DRUG	cyclophosphamide	Given PO
BIOLOGICAL	therapeutic autologous lymphocytes	Undergo autologous PBMC infusion
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-03-01
• First posted: 2013-09-16
• Last updated: 2017-03-15

Locations

1 site across 1 country: United States