A Randomised Phase II Study in Metastatic Melanoma to Evaluate the Efficacy of Adoptive Cellular Therapy with Tumour Infiltrating Lymphocytes (TIL) and Assessment of High versus Low Dose Interleukin-2 - METILDA

The Christie NHS Foundation Trust0 sites90 target enrollmentSeptember 9, 2013

Overview

No summary available.

Registry

who.int

Start Date

September 9, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Inclusion Criteria for TIL Harvest:
•Patients must have histologically confirmed malignant melanoma of cutaneous origin.
•They must have resectable metastatic lesion(s) of at least 2cm in total diameter.
•They must be likely to fulfil the full criteria for TIL therapy at a future date.
•The must give full written informed consent to the surgical procedure and the TIL harvest/storage.
•Inclusion Criteria for TIL Therapy
•Patients must have histologically confirmed malignant melanoma of cutaneous origin with confirmed evidence of progressive metastatic disease and to have failed / refused standard therapies.
•Patients may enter if they have previously had TIL (successfully) harvested and stored at the Manchester Cell Therapy Unit.
•There must be measurable / evaluable disease.
•Patients may have had any previous systemic therapies including anti\-CTLA4 (Ipilimumab) agent provided they are otherwise fit for treatment.

•Exclusions to TIL Harvest are:
•Patients known or found to be serologically positive for Hepatitis B, C, HIV or HTLV.
•Previous allogeneic transplant.
•Patient with ocular/mucosal (or any non\-cutaneous primary site) melanoma.
•Patients who are high medical risks because of non\-malignant systemic disease, including those with, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the lead clinicians opinion would not make the patient a good candidate for this therapy.
•Prior history of malignancies at other sites, with the exception of adequately treated cone\-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
•Patients known or found to be serologically positive for Hepatitis B, C, HIV or HTLV.
•History of systemic autoimmune disease which could be life\-threatening if reactivation occurred (for example hypothyroidism would be permissible, prior rheumatoid arthritis or SLE would not).
•Patients who are likely to require long\-term systemic steroids or other
•Radiotherapy to \>25% skeleton.