drugset / Trial / NCT00200577

Tumor Infiltrating Lymphocytes Adjuvant Therapy of Melanoma

NCT00200577

Phase 3 Completed 70 enrolled Nantes University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this multicentric Phase III study is to confirm the results of the phase I-II study (Dreno B \& Al. Cancer Immunol Immunother 2002; 51: 539-456) which demonstrated the preventive effect of a treatment by TIL (Tumor Infiltrating Lymphocytes) combined with IL2 (Interleukin 2; low dose injected subcutaneously) on the metastatic relapse in the stage III melanoma patients with only one invaded lymphnode.

Timeline

Start
2005-05
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject TIL Unknown
Subject aldesleukin Protein / enzyme biologic 6e+06 iu Subcutaneous

Indications