Pancreatic CancerPhase 3NCT00040092
A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
A Phase 3 study testing Virulizin® in people with Pancreatic Cancer, run by Aptose Biosciences Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Virulizin®
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
About this study
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.
Read the detailed description
A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.
Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.
- Conditions
- Pancreatic Cancer
- Being tested
- Virulizin®
- Keywords
- Virulizin, Immunotherapy, Pancreas, Pancreatic Cancer, clinical trial
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virulizin®Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2002 (estimated)
- Study startJul 2002
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Aptose Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040092
- Sponsor's protocol ID
- LOR/VIR/P03/002
- Status last verified
- Jan 2008
- First submitted
- 19 Jun 2002
- Last updated
- 7 Jan 2008
- Results posted
- No
Publications
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.
PubMed 11139822Liu 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.
PubMed 10762639Warner 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.
PubMed 8174313
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00040092
- Acronym / sponsor ID
- LOR/VIR/P03/002
- Conditions
- Pancreatic Cancer
- Keywords
- Virulizin, Immunotherapy, Pancreas, Pancreatic Cancer, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Aptose Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jul 2005 (actual)
- First posted
- 20 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.
Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virulizin® | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2008.
- Background: PubMed 11139822Ferdinandi 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.
- Background: PubMed 10762639Liu 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.
- Background: PubMed 8174313Warner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Virulizin® in people with Pancreatic Cancer, run by Aptose Biosciences Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00040092, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2008.