drugset / Trial / NCT01005537

Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma

NCT01005537

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective treatment for metastatic melanoma. PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide together with autologous lymphocytes and aldesleukin and to see how well it works in treating patients with metastatic melanoma.

Timeline

Start
2009-06
Primary completion
2010-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous Tumor Infiltrating Lymphocytes Cell therapy Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject aldesleukin Protein / enzyme biologic Intravenous

Indications