V930 First in Man (FIM) Study (V930-002)(COMPLETED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-09-30

Brief Summary

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To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

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Detailed Description

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Conditions

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Cancers Expressing HER-2 and/or CEA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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V930

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No