NCT00040092

Brief Summary

Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2002

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

January 7, 2008

Status Verified

January 1, 2008

Enrollment Period

3 years

First QC Date

June 19, 2002

Last Update Submit

January 4, 2008

Conditions

Pancreatic Cancer

Keywords

VirulizinImmunotherapyPancreasPancreatic Cancerclinical trial

Interventions

Virulizin®DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV) * No previous systemic chemotherapy(unless given as a radiosensitizer). * ECOG Performance Status 0-2 * Life expectancy equal to or greater than 12 weeks * Adequate laboratory and organ functions * Stabilizable pain (stable analgesic intake) * No radiotherapy during 4 weeks prior to trial entry * No evidence of ascites, pleural effusion or third space fluid accumulation * Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Ferdinandi ES, Braun DP, Liu C, Zee BC, Ely G. Virulizin(R) - A review of its antineoplastic activity. Expert Opin Investig Drugs. 1999 Oct;8(10):1721-1735. doi: 10.1517/13543784.8.10.1721.

    PMID: 11139822BACKGROUND

  • Liu C, Ferdinandi ES, Ely G, Joshi SS. Virulizin-2gamma, a novel immunotherapeutic agent, in treatment of human pancreatic cancer xenografts. Int J Oncol. 2000 May;16(5):1015-20. doi: 10.3892/ijo.16.5.1015.

    PMID: 10762639BACKGROUND

  • Warner E, Weinroth J, Chang S, MacDonald M, Strauss B. Phase II trial of Virulizin in patients with pancreatic cancer. Clin Invest Med. 1994 Feb;17(1):37-41.

    PMID: 8174313BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

virulizin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2002

First Posted

June 20, 2002

Study Start

July 1, 2002

Primary Completion

July 1, 2005

Last Updated

January 7, 2008

Record last verified: 2008-01