drugset / Trial / NCT00569296

Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and GM-CSF in Treating Patients With Recurrent, Refractory, or Metastatic Non-Small Cell Lung Cancer

NCT00569296

Phase 1 Terminated 5 enrolled Roger Williams Medical Center
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic non-small cell lung cancer. FUNDING SOURCE--FDA OOPD

Timeline

Start
2007-11
Primary completion
2014-12
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject EGFRBi-armed autologous activated T cells Cell therapy Intravenous
Background aldesleukin Protein / enzyme biologic 300 iu Subcutaneous
Background sargramostim Protein / enzyme biologic 250 ug/m2 Subcutaneous

Indications