NCT02379195

Peginterferon and TIL Therapy for Metastatic Melanoma

T Cell Therapy in Combination With Peginterferon for Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Inge Marie Svane · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide 60 mg/kg are administered i.v on day -7 and -6
DRUG	Fludarabine	Fludarabine 25 mg/m2 are administered i.v on day -5 to -1
BIOLOGICAL	TIL infusion	The maximum number of expanded TILs are infused over 30-45 min on day 0
DRUG	Interleukin-2	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)
DRUG	Peginterferon alfa-2b	Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14.

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-01-01
• Completion: 2018-10-01
• First posted: 2015-03-04
• Last updated: 2020-01-22
• Results posted: 2020-01-22

Locations

1 site across 1 country: Denmark