NCT00250419

Brief Summary

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

November 7, 2005

Last Update Submit

February 9, 2015

Conditions

Cancers Expressing HER-2 and/or CEA

Interventions

V930BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
  • Patients will either be disease free following primary therapy or have advanced disease with a durable response (\>3 months) after standard therapy
  • Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

You may not qualify if:

  • Patients with prior treatment with any HER-2 and/or CEA containing vaccine
  • Patients who have significant cardiac disease
  • Patients with autoimmune disorders
  • Patients who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Diaz CM, Chiappori A, Aurisicchio L, Bagchi A, Clark J, Dubey S, Fridman A, Fabregas JC, Marshall J, Scarselli E, La Monica N, Ciliberto G, Montero AJ. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J Transl Med. 2013 Mar 8;11:62. doi: 10.1186/1479-5876-11-62.

    PMID: 23497415DERIVED

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 10, 2015

Record last verified: 2015-02