drugset / Trial / NCT01081808
Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors
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 advanced solid tumors.
Timeline
- Start
- 2009-10
- Primary completion
- 2014-12
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EGFRBi-armed autologous activated T cells | Cell therapy | 5e+09 cells | Intravenous |
| Subject | EGFRBi-armed autologous activated T cells | Cell therapy | 1e+10 cells | Intravenous |
| Subject | EGFRBi-armed autologous activated T cells | Cell therapy | 2e+10 cells | Intravenous |
| Subject | EGFRBi-armed autologous activated T cells | Cell therapy | 4e+10 cells | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 300000 iu | Subcutaneous |
| Background | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |