drugset / Trial / NCT00096382

Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00096382

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.

Timeline

Start
2004-09
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy Intravenous
Subject aldesleukin Protein / enzyme biologic 125000 iu/kg Intravenous
Subject aldesleukin Protein / enzyme biologic 720000 iu/kg Intravenous
Background filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications