Breast CancerPhase 1NCT00027534
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
A Phase 1 study testing TRICOM-CEA(6D) in people with Breast Cancer and Colorectal Cancer, run by Michael Morse, MD at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Gallbladder Cancer
- What is being tested?
- TRICOM-CEA(6D)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Oct 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced or metastatic malignancy expressing CEA
- Metastatic disease meeting one of the following criteria:
- Measurable or nonmeasurable
- History of metastases but no current evidence of disease, meeting one of the following criteria:
- Unresectable peritoneal or lymph node metastases that cannot be detected by imaging
- Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%)
- Must have completed treatment that rendered no evidence of disease within the past year
- CEA-expressing malignancy is defined by any of the following:
- Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining)
- CEA level in peripheral blood greater than 2.5 µg/L
- Tumor known to be universally CEA positive (e.g., colon and rectal cancer)
- Received prior therapy with possible survival benefit or refused such therapy
- Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over Sex
- Male or female Menopausal status
- Not specified Performance status
- Karnofsky 70-100% Life expectancy
- More than 6 months
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute lymphocyte count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic
- Bilirubin less than 2.0 mg/dL
- SGOT/SGPT less than 1.5 times upper limit of normal
- No active acute or chronic viral hepatitis
- Hepatitis B surface antigen negative
- Hepatitis C negative
- No other hepatic disease that would preclude study entry
Renal
- Creatinine less than 2.5 mg/dL
- No active acute or chronic urinary tract infection
Cardiovascular
- No New York Heart Association class III or IV heart disease Immunologic
- HIV negative
- No history of autoimmune disease, including, but not limited to, the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Ankylosing spondylitis
- Scleroderma
- Multiple sclerosis
- No allergy to eggs or any component of study vaccine Other
- No active acute or chronic infection
- No concurrent serious acute or chronic illness that would preclude study entry
- No other medical or psychological impediment that would preclude study entry
- No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy and recovered
- No other concurrent immunotherapy
Chemotherapy
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy
- At least 4 weeks since prior hormonal therapy and recovered
- At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies
- No concurrent steroids
Radiotherapy
- Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since any other prior therapy (including experimental therapy) and recovered
- No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27705
About this study
Official title: A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA.
- Assess the CEA-specific immune response of patients treated with this regimen.
- Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity.
Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.
- Conditions
- Breast Cancer, Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer
- Being tested
- TRICOM-CEA(6D)
- Keywords
- recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent gallbladder cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Liver Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRICOM-CEA(6D)Biological
Also called recombinant fowlpox-CEA(6D)/TRICOM vaccine
dendritic cells loaded with TRICOM-CEA(6D)
| Study group | Role | What they receive |
|---|---|---|
| TRICOM-CEA(6D) | Experimental | Subjects receiving TRICOM-CEA(6D) Receives: Biological: TRICOM-CEA(6D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.
Measured: 12-36 weeks
Secondary outcomes (1)
Immune response
The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated
Measured: 12-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Morse, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Michael Morse, MD, Duke University
- Investigators
- Herbert K. Lyerly, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027534
- Sponsor's protocol ID
- 2840
- Other IDs
- 1R21CA094523, 2840, CDR0000069041
- Status last verified
- Sep 2014
- First submitted
- 7 Dec 2001
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
- ClinicalTrials.gov ID
- NCT00027534
- Acronym / sponsor ID
- 2840
- Conditions
- Breast Cancer, Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer
- Keywords
- recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Michael Morse, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 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.
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
Detailed description
OBJECTIVES:
- Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA.
- Assess the CEA-specific immune response of patients treated with this regimen.
- Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity.
Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 6-18 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 |
|---|---|---|
| TRICOM-CEA(6D) | Experimental | Biological: TRICOM-CEA(6D)Subjects receiving TRICOM-CEA(6D) |
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 |
|---|---|---|
| TRICOM-CEA(6D)Also: recombinant fowlpox-CEA(6D)/TRICOM vaccinedendritic cells loaded with TRICOM-CEA(6D) | Biological | TRICOM-CEA(6D) |
Primary outcome
Safety
Time frame: 12-36 weeks
The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.
1 secondary outcome
Immune response
Time frame: 12-36 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 8 Sep 2014.
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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.
Herbert K. Lyerly, MD study chair
Duke Cancer Institute
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 TRICOM-CEA(6D) in people with Breast Cancer and Colorectal Cancer, run by Michael Morse, MD 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: finished, as of the sponsor's last update on 8 Sep 2014. 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?
Safety (time frame: 12-36 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 8 Sep 2014.