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)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00647114
First received: March 26, 2008
Last updated: March 25, 2014
Last verified: March 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

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: V930-003, 2007_671
Study First Received: March 26, 2008
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Cancers expressing HER-2 and/or CEA

ClinicalTrials.gov processed this record on April 21, 2014