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) - Full Text View

Purpose

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

Condition	Intervention	Phase
Cancer	Biological: V930 Biological: V932	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To determine the safety and tolerability of V930/V932 followed by EP in cancer patients [ Time Frame: Week 22 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay [ Time Frame: Week 22 ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	August 2007
Study Completion Date:	April 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 V930	Biological: 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.
Experimental: 2 V932	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).

Detailed Description:

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

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647114

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00647114 History of Changes
Other Study ID Numbers:	2007_671, V930-003
Study First Received:	March 26, 2008
Last Updated:	April 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Cancers expressing HER-2 and/or CEA

ClinicalTrials.gov processed this record on May 16, 2013