A Study to Test V930/V932 in Patients With Cancers Expressing Human Epidermal Growth Factor Receptor 2 (HER-2) and/or Carcinoembryonic Antigen (CEA)(V930-003)(COMPLETED)

Study Overview
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Brief Summary
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Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.

Detailed Description
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The optional followup period for this study is 1 year after the last vaccination.

Official Title
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A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA

Conditions
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Cancer

Intervention / Treatment
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* Biological: V930
* Biological: V932


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have completed surgical treatment for his/her primary disease at least 1 month prior to enrollment Patient must not be pregnant 3 days prior to enrollment Exclusion Criteria: Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent Patient has had their spleen removed or has a history of autoimmune disorders Patient is a regular user of any illicit drugs or has used within the past year of drug or alcohol abuse Patient is pregnant or breastfeeding or is expecting to conceive anytime following the study Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive Patient has a known history of Hepatitis B or C Patient has received a vaccine for any disease or condition within one month of enrollment Patient has a primary central nervous system tumor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>V930 | Biological: V930<br>* V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses.<br>|
| Experimental: 2<br>V932 | Biological: V932<br>* V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of V930/V932 followed by EP in cancer patients |  | Week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay |  | Week 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancers expressing HER-2 and/or CEA