Status:
COMPLETED
V930 First in Man (FIM) Study (V930-002)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cancers Expressing HER-2 and/or CEA
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.
Eligibility Criteria
Inclusion
- Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
- Patients will either be disease free following primary therapy or have advanced disease with a durable response (\>3 months) after standard therapy
- Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis
Exclusion
- Patients with prior treatment with any HER-2 and/or CEA containing vaccine
- Patients who have significant cardiac disease
- Patients with autoimmune disorders
- Patients who are pregnant or lactating
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00250419
Start Date
September 1 2005
End Date
September 1 2008
Last Update
February 10 2015
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