T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. A Pilot Study.
Phase 1
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
Melanoma
Both
Melanoma
Trial Information
T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. A Pilot Study.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
toxicity
Outcome Time Frame:
week 0 to 20
Safety Issue:
Yes
Principal Investigator
Inge Marie Svane, Professor, MD
Investigator Role:
Study Director
Investigator Affiliation:
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Authority:
Denmark: Danish Medicines Agency
Study ID:
MM0909
NCT ID:
NCT00937625
Start Date:
June 2009
Completion Date:
June 2012
Related Keywords:
- Melanoma
- Melanoma
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