NCT00937625

T-cell Based Immunotherapy for of Melanoma

T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Inge Marie Svane · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma. Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response. After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	cyclophosphamide, fludarabine, T-cells, Interleukin-2	Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-07-13
• Last updated: 2015-08-18

Locations

1 site across 1 country: Denmark