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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014