drugset / Trial / NCT00945269

Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma

NCT00945269 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: White blood cells that have been treated in a laboratory may be able to kill tumor cells in patients with melanoma. Aldesleukin and denileukin diftitox may stimulate the white blood cells to kill melanoma cells. Giving therapeutic autologous lymphocyte therapy together with aldesleukin and denileukin diftitox may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving therapeutic autologous lymphocytes together with aldesleukin and denileukin diftitox and to see how well it works in treating patients with stage III-IV melanoma

Timeline

Start
2009-07
Primary completion
2011-01
Completion
2011-01

Outcome

Outcome not reported

Stopped: “ONTAK has been pulled off the market for further testing. Subsequently, EISAI will no longer be supporting clinical trials that utilize this drug.”

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic — Subcutaneous
Subject denileukin diftitox Protein / enzyme biologic — Intravenous
Subject therapeutic autologous lymphocytes Cell therapy — Intravenous

Indications