drugset / Trial / NCT00324623

Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma

NCT00324623

Phase 1 Completed 8 enrolled Prof. Serge Leyvraz
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used to prepare the body for other treatments, such as cellular adoptive immunotherapy. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. Giving cyclophosphamide together with fludarabine followed by biological therapy may be an effective treatment for metastatic melanoma. PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in treating patients with metastatic melanoma.

Timeline

Start
2005-09
Primary completion
2011-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 30 mg/kg Intravenous
Subject IMP321 Protein / enzyme biologic 25 ug
Subject IMP321 Protein / enzyme biologic 250 ug
Subject Melan-A vaccine Unknown Subcutaneous
Subject autologous PBMCs Cell therapy
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications