At a glance
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T Cell Therapy in Combination With Peginterferon for Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine, and 3 other interventions for Metastatic Melanoma. Completed, enrolled 12 participants across 1 site.
Detailed Summary
Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from the patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 are administered to support T cell activation and proliferation in vivo. In this trial the therapy is combined with peginterferon (the pegylated form of interferon alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA expression on melanoma cells and are hypothesized to synergize with TIL therapy.
Study Details
Timeline
Interventions
Cyclophosphamide 60 mg/kg are administered i.v on day -7 and -6
Fludarabine 25 mg/m2 are administered i.v on day -5 to -1
The maximum number of expanded TILs are infused over 30-45 min on day 0
Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)
Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14.