Colonic NeoplasmsPhase 1NCT00054912
An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
A Phase 1 study testing EP2101 in people with Colonic Neoplasms and Colorectal Neoplasms, run by Epimmune at 9 sites in United States.
Trial summary
EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Colorectal Neoplasms
- What is being tested?
- EP2101
- How many people
- 18 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2003to not given
- Phase
- Phase 1
- 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
- Confirmed diagnosis of Colon Cancer, stage III
- At least four weeks following prior standard treatment, with no evidence of disease
- Must use adequate birth control
Who cannot join
- Prior cancer vaccine therapy or concurrent participation in any other investigational study
- A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
- A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
- Women who are pregnant, intend to become pregnant, or who are breast feeding
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New York Oncology Hematology
Albany, New York, 12208
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
University of Southern California School of Medicine
Los Angeles, California, 90033
Cancer Centers of Florida
Orlando, Florida, 32806
University of California, San Diego
San Diego, California, 92037
University of Washington
Seattle, Washington, 91895
Cancer Care Northwest
Spokane, Washington, 99218
Tyler Cancer Center
Tyler, Texas, 75702
About this study
Official title: An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer
EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.
- Conditions
- Colonic Neoplasms, Colorectal Neoplasms
- Being tested
- EP2101
- Keywords
- vaccine, colon, cancer, colorectal, neoplasm, Colonic Cancer, Colon Cancer, Cancer of the Colon
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP2101Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2003 (estimated)
- Study startFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Epimmune
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054912
- Sponsor's protocol ID
- EP2101-102
- Status last verified
- Apr 2004
- First submitted
- 12 Feb 2003
- Last updated
- 9 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer
- ClinicalTrials.gov ID
- NCT00054912
- Acronym / sponsor ID
- EP2101-102
- Conditions
- Colonic Neoplasms, Colorectal Neoplasms
- Keywords
- vaccine, colon, cancer, colorectal, neoplasm, Colonic Cancer, Colon Cancer, Cancer of the Colon
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- EpimmuneIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- First posted
- 14 Feb 2003 (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.
EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 (3 listed)
- Confirmed diagnosis of Colon Cancer, stage III
- At least four weeks following prior standard treatment, with no evidence of disease
- Must use adequate birth control
Key exclusion criteria (4 listed)
- Prior cancer vaccine therapy or concurrent participation in any other investigational study
- A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
- A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
- Women who are pregnant, intend to become pregnant, or who are breast feeding
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 |
|---|---|---|
| EP2101 | Biological | – |
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 9 Apr 2008.
- Related InfoLink provided by the sponsor.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EP2101 in people with Colonic Neoplasms and Colorectal Neoplasms, run by Epimmune at 9 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 9 Apr 2008.