drugset / Trial / NCT00704938

Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer

NCT00704938 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.

Timeline

Start
2008-06
Primary completion
2009-08
Completion
2009-08

Outcome

Outcome not reported

Stopped: “Terminated due to withdrawal of support from our collaborator.”

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 720000 iu/kg Intravenous
Subject anti-p53 T-cell receptor-transduced peripheral blood lymphocytes Cell therapy 1e+08 cells Intravenous
Subject anti-p53 T-cell receptor-transduced peripheral blood lymphocytes Cell therapy 5e+10 cells Intravenous
Subject autologous dendritic cell-adenovirus p53 vaccine Cell therapy 2e+08 cells Subcutaneous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous