T-cell Based Immunotherapy for of Melanoma
Phase 1
Completed
- Conditions
- Melanoma
- Registration Number
- NCT00937625
- Lead Sponsor
- Inge Marie Svane
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.
Exclusion Criteria
- Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method toxicity week 0 to 20
- Secondary Outcome Measures
Name Time Method tumor response week 8 and every 3rd week until progression immune response week 0 to 20
Trial Locations
- Locations (1)
Department of Oncology, Copenhagen University Hospital, Herlev
🇩🇰Herlev, Denmark