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Completed

NCT Number: NCT00647114

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)

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

V930

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.

V932

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).

Primary outcomes

  1. To determine the safety and tolerability of V930/V932 followed by EP in cancer patients

    Time frame: Week 22

Secondary outcomes

  1. To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay

    Time frame: Week 22

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Mar 31, 2008
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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