Status:
COMPLETED
Active Specific Intranodal Immunotherapy of Recombinant Vaccinia Virus in Locally Advanced to Metastatic Melanoma
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess intranodal immunotherapy in locally advanced to metastatic melanoma patients (American Joint Committee on Cancer \[AJCC\] stages IIb to IV). For this, the inves...
Detailed Description
The investigators have conducted a phase I/II clinical trial based on the intradermal administration to stage III/IV melanoma patients of a recombinant vaccinia virus encoding tumor associated antigen...
Eligibility Criteria
Inclusion
- Patients older than 18 years
- Histologically proven melanoma in AJCC stages IIb to IV
- Resected, recurrent or disseminated disease
- HLA-A2.1 MHC phenotype
- Karnofsky performance status equal or higher than 70%
Exclusion
- Patients younger than 18 years
- Pregnancy or inability to perform anticonception
- MHC phenotype other than HLA-A2.1
- Other concurrent malignant disease
- Estimated life expectancy of less than 6 months
- Allergic skin diseases, including eczema, psoriasis and neurodermitis
- Fever or active infection of the respiratory system
- Concurrent severe cardiac or pulmonary disease (New York Heart Association \[NYHA\] III and IV)
- Significant impairment of liver or kidney function (bilirubin \> 30umol/l, GOT \>2.5xN, GPT \>2.5xN, alkaline phosphatase \>2.5xN, creatinine \>1.5xN adapted to the age)
- Impairment of the immune system (leucocyte counts \<3000/mm3 or granulocytes counts \<1500/mm3)
- Concurrent immunosuppressive therapy
- Preexisting severe anemia (hemoglobin lower than 80 g/l)
- Preexisting thrombocytopenia (platelet counts lower than 75,000/ul)
- Ongoing chemotherapy or chemotherapy completed less than 6 weeks before enrollment in the trial
- Any medical or psychiatric condition which, in the opinion of the treating physician or principal investigator, would unacceptably reduce the safety of the proposed treatment, would impair the delivery of treatment, or would preclude obtaining voluntary informed consent
- Patients receiving any other concurrent investigational treatment, or any other concurrent treatment for their cancer
- Patients who cannot avoid close contact with children less than 3 years of age or with immunocompromised household members
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00116597
Start Date
November 1 2002
End Date
December 1 2008
Last Update
December 2 2009
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031