Colorectal CancerEarly Phase 1NCT00091286
Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer
A Early Phase 1 study testing HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine in people with Colorectal Cancer, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2003to 15 Feb 2008
- Phase
- Early 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer
- Stage IIB, III, or IV disease
- HLA-A2- or -A3-positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Hemoglobin > 9 g/dL
- Platelet count > 100,000/mm^3
Hepatic
- Liver function tests ≤ 2.5 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No New York Heart Association class III or IV heart disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known or suspected allergies to any component of the study drug
- No active connective tissue disease requiring medications
- No systemic autoimmune disease with visceral involvement
- No uncontrolled diabetes
- No other severe autoimmune disease
- No medical contraindication or potential problem that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 30 days since prior immunotherapy
- More than 30 days since prior growth factors
- More than 30 days since prior allergy shots
- No prior vaccination with any study peptides for malignancy
Chemotherapy
- More than 30 days since prior chemotherapy
Endocrine therapy
- More than 30 days since prior steroids
Radiotherapy
- More than 30 days since prior radiotherapy
Surgery
- More than 30 days since prior surgery
Other
- At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer
- No concurrent illegal drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
About this study
Official title: Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.
Read the detailed description
OBJECTIVES:
- Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune response in patients with stage IIB, III, or IV colorectal cancer.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine
- Keywords
- recurrent colon cancer, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer, stage IIB rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Peptide Vaccine + Montanide + GM-CSF | Experimental | Colon peptide mixture (100 mcg each of the 4 peptides) plus 190 mcg of tetanus toxoid peptide, plus GM-CSF (110 mcg) in Montanide ISA-51 adjuvant Receives: Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the 4-peptide mixture
Adverse events
Measured: 30 days following last vaccine
Number of patients with an immune response to the peptides
T cell responses against the peptides as measured in the sentinel immunized node
Measured: through Day 22
Secondary outcomes (1)
Immunogenicity of the peptide mixture measured in the peripheral blood
T cell responses against the peptides and/or tumor
Measured: through Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study start24 Mar 2003
- Primary completion15 Feb 2008
- Study completion15 Feb 2008
Why it stopped: Slow accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Charles M. Friel, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091286
- Sponsor's protocol ID
- 9976
- Other IDs
- UVACC-GI37, UVACC-23302
- Status last verified
- Mar 2020
- First submitted
- 7 Sep 2004
- Last updated
- 30 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00091286
- Acronym / sponsor ID
- 9976
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accruals
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Mar 2003 (actual)
- Primary completion
- 15 Feb 2008 (actual)
- Study completion
- 15 Feb 2008 (actual)
- First posted
- 9 Sep 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.
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.
Detailed description
OBJECTIVES:
- Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune response in patients with stage IIB, III, or IV colorectal cancer.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptide Vaccine + Montanide + GM-CSF | Experimental | Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccineColon peptide mixture (100 mcg each of the 4 peptides) plus 190 mcg of tetanus toxoid peptide, plus GM-CSF (110 mcg) in Montanide ISA-51 adjuvant |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine | Biological | Peptide Vaccine + Montanide + GM-CSF |
Primary outcome
Safety of the 4-peptide mixture
Time frame: 30 days following last vaccine
Adverse events
Number of patients with an immune response to the peptides
Time frame: through Day 22
T cell responses against the peptides as measured in the sentinel immunized node
1 secondary outcome
Immunogenicity of the peptide mixture measured in the peripheral blood
Time frame: through Day 22
Results and safety
The study was stopped early (reason given: Slow accruals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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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.
Charles M. Friel, MD study chair
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine in people with Colorectal Cancer, run by Craig L Slingluff, Jr 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?
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: stopped early, as of the sponsor's last update on 30 Mar 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Slow accruals). 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.
What does the primary outcome measure?
Safety of the 4-peptide mixture (time frame: 30 days following last vaccine). The study lists 2 primary outcomes in all. 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 30 Mar 2020.