TIL Therapy in Metastatic Melanoma and IL2 Dose Assessment
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
This is a two arm, open-labelled phase II randomised trial of Tumour Infiltrating Lymphocytes
(TIL) in metastatic melanoma patients given with preconditioning chemotherapy and
Interleukin-2 (IL2). Eligible patients will undergo surgical tumour excision from which TIL
will be derived, cultured and expanded. Patients will receive preconditioning chemotherapy
with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5
to day -1. The autologous TILs will be re-infused on day 0 and the patients will receive up
to 12 doses of intravenous High Dose Interleukin-2 (HD-IL2) or Low Dose Interleukin-2
(LD-IL2) depending on the randomised arm.
The primary objectives are response rate assessed and compared by CT scans carried out at
week 6, week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and
tolerability of TIL therapy with HD-IL2 versus LD-IL2.
Phase:
Phase 2
Details
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborator:
National Institute for Health Research, United Kingdom