Peginterferon and TIL Therapy for Metastatic Melanoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

January 31, 2018

Study Completion Date

October 31, 2018

Conditions
Metastatic Melanoma
Interventions
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.

Trial Locations (1)

2730

Center for Cancer Immune Therapy, Dept. of Haematology/Oncology, Copenhagen

All Listed Sponsors
lead

Inge Marie Svane

OTHER

NCT02379195 - Peginterferon and TIL Therapy for Metastatic Melanoma | Biotech Hunter | Biotech Hunter