Trials / Completed
CompletedNCT00204594
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.
Detailed description
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with dose escalation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rM28 | |
| DRUG | autologous PBMCs |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2005-09-20
- Last updated
- 2013-01-16
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00204594. Inclusion in this directory is not an endorsement.