Stage III Colon CancerPhase 1NCT01890213
Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer
A Phase 1 study testing AVX701 in people with Stage III Colon Cancer, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Colon Cancer
- What is being tested?
- AVX701
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2019
- 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
- Histologically confirmed stage III colorectal cancer as determined by AJCC 7th edition.
- Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements:
- Chemotherapy must have consisted of a 5-fluorouracil-based regimen with or without oxaliplatin for at least 6 cycles or capecitabine with or without oxaliplatin for 4 cycles.
- Chemotherapy must have been completed within 1-6 months of starting study treatment.
- Subjects with rectal cancer must have received chemotherapy meeting the following requirements:
- Neoadjuvant chemotherapy, if utilized, must have consisted of a 5-fluorouracil-based regimen (or capecitabine) with radiation
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- Adjuvant chemotherapy must have consisted of a 5-fluorouracil-based regimen with or without oxaliplatin for at least 6 cycles or capecitabine with or without oxaliplatin for 4 cycles
- Chemotherapy must have been completed within 1-6 months of starting study treatment.
- Karnofsky performance status greater than or equal to 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, Hgb ≥ 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets ≥ 100,000/microliter
- Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.
- Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol
Who cannot join
- Patients with active cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. There 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.
- Evidence of metastatic disease.
- Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
- Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled superficial bladder cancer.
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- Presence of an active acute or chronic infection including: a urinary tract infection , HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
- Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
- Patients with allergies to any component of the vaccine will be excluded from the protocol.
- Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
- Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Pilot Study of Active Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer
This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine.
- Conditions
- Stage III Colon Cancer
- Being tested
- AVX701
- Keywords
- alphavirus, colon cancer, immune response, CEA
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX701Biological
Also called VRP-CEA(6D)
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | AVX701 Vaccine:4 x 10EE8 IU intramuscularly every 3 weeks for 4 total immunizations Receives: Biological: AVX701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2017
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colon CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- AlphaVax, Inc.
- Responsible party
- Principal investigator, Michael Morse, MD, Duke University
- Investigators
- Michael Morse, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890213
- Sponsor's protocol ID
- Pro00045976
- Other IDs
- IND13372
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2013
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Active Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01890213
- Acronym / sponsor ID
- Pro00045976
- Conditions
- Stage III Colon Cancer
- Keywords
- alphavirus, colon cancer, immune response, CEA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- AlphaVax, Inc.
- Study start
- Nov 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Jul 2013 (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.
This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: AVX701AVX701 Vaccine:4 x 10EE8 IU intramuscularly every 3 weeks for 4 total immunizations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed stage III colorectal cancer as determined by AJCC 7th edition.
- Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements:
- Subjects with rectal cancer must have received chemotherapy meeting the following requirements:
- Karnofsky performance status greater than or equal to 70%
- Estimated life expectancy > 6 months and not expected to require further systemic chemotherapy for at least 3 months.
Key exclusion criteria (11 listed)
- Patients with active cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. There 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.
- Evidence of metastatic disease.
- Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
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 |
|---|---|---|
| AVX701Also: VRP-CEA(6D) | Biological | Vaccine |
Primary outcome
Number of participants with adverse events
Time frame: 12 weeks
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 18 Jul 2019.
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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.
Michael Morse, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVX701 in people with Stage III Colon Cancer, run by Duke University at 1 site 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 15 inclusion and 11 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
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 18 Jul 2019.