M14TIL


Protocolnummer:
NL 47475.000.14

Ziekenhuizen:
NKI / A.v.L ziekenhuis Amsterdam

Titel:
Randomized Phase lll Study Comparing a Non-myeloblative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Tumor Infiltrating Lymphocytes and Interleukin-2 to Standard Ipilimumab treatment in Metastatic Melanoma.

Behandeling:
Arm A- ipilimumab 3mg/kg 4 times or Arm B - Tumor Infiltrating lymphocytes ( 1:1 randomized)

Stadium:
Stadium irresectable IIIc/IV

Belangrijkste in/exclusiecriteria:
In: a resectable metastatic lesion (= or > 3 cm) and willing to undergo a resection for experimental purposes, absolute neutrophil count greater than 1.5 x 109/L without support of filgrastim, platelet count greater than 100x 109/L , seronegative for HIV antibody and lues. Ex: metastatic ocular or mucosal melanoma, history of more than two CNS metastases, respiratory distress, coronary revascularization.

Contactpersoon:
Prof. J. Haanen

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