Pancreatic CancerPhase 3NCT00088660
PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
A Phase 3 study testing PANVAC™-VF in people with Pancreatic Cancer, run by Therion Biologics Corporation at 62 sites in United States.
Trial summary
The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy. 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?
- PANVAC™-VF
- How many people
- 250 participants
- Where
- 62 sitesUnited States
- Study dates
- Jun 2004to not given
- 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
Who may be able to join
- Patients > 18 years of age who have been vaccinated against smallpox;
- Histologically confirmed diagnosis of adenocarcinoma of the pancreas;
- Patient has metastatic (Stage IV) disease;
- ECOG performance status 0-1;
- Failed a gemcitabine-containing chemotherapeutic regimen within 3 months of study entry.
Who cannot join
- Prior or concurrent immunotherapy for cancer;
- Radiation therapy within 28 days prior to registration;
- Systemic corticosteroid therapy (except inhaled or topical steroids) within 28 days of registration;
- Significant cardiovascular abnormalities or diseases;
- Known positive for HIV, hepatitis B and/or C;
- Evidence of immunodeficiency or immune suppression.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
New York Oncology Hematology
Albany, New York, 12208
Hematology Oncology Life Center
Alexandria, Louisiana, 71301
Arlington Cancer Center
Arlington, Texas, 76012
University of Colorado Health Science Center
Aurora, Colorado, 80045
Franklin Square Hospital
Baltimore, Maryland, 21237
Medical Oncology, LLC
Baton Rouge, Louisiana, 70809
St. Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Tufts-New England Medical Center, The Neeley Center for Clinical Research
Boston, Massachusetts, 02111
Gabrail Cancer Center
Canton, Ohio, 44718
Oncology Associates
Cedar Rapids, Iowa, 52403
Charleston Hematology Oncology
Charleston, South Carolina, 29403
Charleston Cancer Center
Charleston, South Carolina, 29406
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Josephine Ford Cancer Center
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Texas Cancer Care
Fort Worth, Texas, 76104
Great Falls Clinic, LLP
Great Falls, Montana, 59405
Greeley Medical Clinic
Greeley, Colorado, 80631
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Dr. H. Alejandro Preti, F.A.C.P.
Houston, Texas, 77030
Elkins Pancreas Center
Houston, Texas, 77030
Jupiter Medical Center
Jupiter, Florida, 33458
Kansas City Cancer Center
Kansas City, Missouri, 64111
Dayton Oncology Hematology
Kettering, Ohio, 45409
Moores UCSD Cancer Center
La Jolla, California, 92093
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40536
Pacific Shores Medical Group
Long Beach, California, 90813
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Loveland Hematology Oncology
Loveland, Colorado, 80538
Jayne Gurtler, MD and Laura Brinz, MD APMC
Metairie, Louisiana, 70006
VA Medical Center
Miami, Florida, 33125
Jackson Memorial Hospital
Miami, Florida, 33136
Sylvester Cancer Center
Miami, Florida, 33136
Medical Consultants Ltd.
Milwaukee, Wisconsin, 53215
Winthrop Oncology/Hematology Division
Mineola, New York, 11501
University of South Alabama/ Cancer Research Institute
Mobile, Alabama, 36693
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Tulane Cancer Center
New Orleans, Louisiana, 70112
Columbia Presbyterian Medical Center
New York, New York, 10032
Norwalk Hospital/ Whittingham Cancer Center
Norwalk, Connecticut, 06856
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Chao Family Comprehensice Cancer Center
Orange, California, 92868
Temple University Cancer Center
Philadelphia, Pennsylvania, 19140
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, 92270
Virginia Cancer Institute
Richmond, Virginia, 23220
Scripps Cancer Center
San Diego, California, 92121
VA San Diego Healthcare System
San Diego, California, 92161
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
Swedish Cancer Institute
Seattle, Washington, 98104
Cancer Care Northwest
Spokane, Washington, 99218
Saint Louis University Cancer Center
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Tyler Cancer Center
Tyler, Texas, 75702
Carle Cancer Center
Urbana, Illinois, 61801
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Washington Hospital Cancer Center
Washington D.C., District of Columbia, 20010
Texas Cancer Care
Weatherford, Texas, 76086
About this study
Official title: A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen
The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy.
Read the detailed description
PANVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the body can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer.
All patients will be required to sign an informed consent prior to the performance of any study-related procedures. Patients will be screened for eligibility within 14 days prior to their anticipated treatment start date (Day 0). Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a treatment assignment. The ratio of active treatment to control is 1:1 (PANVAC-VF: best supportive care or palliative chemotherapy).
- Conditions
- Pancreatic Cancer
- Being tested
- PANVAC™-VF
- Keywords
- Metastatic
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANVAC™-VFBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Therion Biologics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088660
- Sponsor's protocol ID
- TBC-PAN-003
- Status last verified
- Feb 2006
- First submitted
- 30 Jul 2004
- Last updated
- 8 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00088660
- Acronym / sponsor ID
- TBC-PAN-003
- Conditions
- Pancreatic Cancer
- Keywords
- Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- Therion Biologics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- First posted
- 2 Aug 2004 (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.
The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy.
Detailed description
PANVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the body can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer.
All patients will be required to sign an informed consent prior to the performance of any study-related procedures. Patients will be screened for eligibility within 14 days prior to their anticipated treatment start date (Day 0). Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a treatment assignment. The ratio of active treatment to control is 1:1 (PANVAC-VF: best supportive care or palliative chemotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 18 years of age who have been vaccinated against smallpox;
- Histologically confirmed diagnosis of adenocarcinoma of the pancreas;
- Patient has metastatic (Stage IV) disease;
- ECOG performance status 0-1;
- Failed a gemcitabine-containing chemotherapeutic regimen within 3 months of study entry.
Key exclusion criteria (6 listed)
- Prior or concurrent immunotherapy for cancer;
- Radiation therapy within 28 days prior to registration;
- Systemic corticosteroid therapy (except inhaled or topical steroids) within 28 days of registration;
- Significant cardiovascular abnormalities or diseases;
- Known positive for HIV, hepatitis B and/or C;
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 |
|---|---|---|
| PANVAC™-VF | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2006.
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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.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PANVAC™-VF in people with Pancreatic Cancer, run by Therion Biologics Corporation at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 8 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
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 8 Feb 2006.