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 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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

V930

Group Type EXPERIMENTAL

V930

Intervention Type BIOLOGICAL

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.

2

V932

Group Type EXPERIMENTAL

V932

Intervention Type BIOLOGICAL

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).

Interventions

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V930

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.

Intervention Type BIOLOGICAL

V932

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).

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No