NCT00529984

Brief Summary

STUDY OBJECTIVES

  1. 1.The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies.
  2. 2.The secondary objectives are to evaluate CEA-specific immune response to the immunizations and obtain preliminary data on response rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

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, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

September 12, 2007

Last Update Submit

July 11, 2012

Conditions

Colorectal CancerBreast CancerLung CancerPancreatic CancerColon Cancer

Keywords

CEACEA-expressing malignanciesMetastatic malignanciesVRP VaccineAlphavirus repliconsMolecular therapeuticsStage III colon cancer

Outcome Measures

Primary Outcomes (1)

  • determine the safety of immunization with CEA(6D) VRP

    2.5 years

Secondary Outcomes (1)

  • evaluate CEA-specific immune response to immunizations

    3 years

Study Arms (5)

Cohort 1

EXPERIMENTAL
Biological: AVX701

Cohort 2

EXPERIMENTAL
Biological: AVX701

Cohort 3

EXPERIMENTAL
Biological: AVX701

Cohort 4

EXPERIMENTAL
Biological: AVX701

Cohort 5

EXPERIMENTAL
Biological: AVX701

Interventions

AVX701BIOLOGICAL

4 doses of AVX701 at 4e7 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • Cohorts 1-4 only:
  • Histologically confirmed diagnosis of metastatic malignancy due to a tumor expressing CEA.
  • The tumor must express CEA as defined by immunohistochemical staining, CEA blood level, or a tumor known to be universally CEA positive.
  • Must have received treatment with standard therapy having a possible overall survival benefit or refused such therapy.
  • Must have received and progressed through at least one line of palliative chemotherapy for colorectal, breast, lung, or pancreatic cancer. For other malignancies, if a first line therapy with survival or palliative benefit exists, it should have been administered and there should have been progressive disease.
  • Cohort 5 Only:
  • Histologically confirmed colon cancer (rectal cancer excluded). Since colon cancer is nearly universally CEA positive, CEA staining is not required.
  • Documented stage III colon cancer with no evidence of disease.
  • One to six months following standard post-operative adjuvant treatment, which should have consisted of 5-fluorouracil and folinic acid or capecitabine with or without oxaliplatin for 4-6 months)
  • All Cohorts:
  • Karnofsky performance status ≥ 70%.
  • Estimated life expectancy \> 6 months and not expected to require further systemic chemotherapy for at least 3 months.
  • Age ≥ 18 years.
  • Adequate hematologic function (WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/microliter).
  • Adequate renal and hepatic function, (serum creatinine \< 1.5 mg/dL, bilirubin ≤ 1.5 mg/dL, and ALT and AST ≤ 2.5 x upper limit of normal).
  • +4 more criteria

You may not qualify if:

  • Concurrent cytotoxic chemotherapy or radiation therapy (must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy and study treatment).
  • Patients with previously resected brain metastases will be permitted if a CT or MRI scan shows no metastasis within 1 month before enrollment.
  • History of autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsLung NeoplasmsPancreatic NeoplasmsColonic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Michael Morse, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

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

September 12, 2007

First Posted

September 14, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

US(1)