Colorectal CancerPhase 2NCT00012246
Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract
A Phase 2 study testing carcinoembryonic antigen peptide 1-6D, incomplete Freund's adjuvant and sargramostim in people with Colorectal Cancer and Esophageal Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer
- What is being tested?
- carcinoembryonic antigen peptide 1-6D, incomplete Freund's adjuvant and sargramostim
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jul 2006
- Phase
- Phase 2
- 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 stage II, III, or IV adenocarcinoma of the gastrointestinal tract originating in 1 of the following:
- Esophagus
- Stomach
- Pancreas
- Small intestine
- Colon or rectum
- Gall bladder
- Extrahepatic bile ducts
- Ampulla of Vater
- Completed standard therapy and at risk of recurrent disease OR has relatively stable metastatic disease and a life expectancy of at least 6 months
- Carcinoembryonic antigen (CEA)-producing tumor as evidenced by detectable blood levels of CEA or positive for CEA on immunohistochemical staining
- Human Leukocyte Antigen (HLA)-A2+
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Southwest Oncology Group (SWOG) 0-1
Life expectancy:
- See Disease Characteristics
Hematopoietic:
- White Blood Count (WBC) at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic:
- Serum Glutamic Oxalacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times upper limit of normal
- Hepatitis B and C negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- No other prior malignancy unless currently disease free and off all therapy for that malignancy
- Early skin cancer allowed
- No AIDS
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 30 days after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- At least 4 weeks since prior surgery
Other:
- No other concurrent therapy for malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0209
About this study
Official title: A Trial Of Vaccination With The Carcinoembryonic Antigen (CEA) Peptide Cap 1-6D With Montanide ISA 51 Adjuvant Or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) In HLA-A2+ Patients With CEA Producing Adenocarcinomas Of Gastrointestinal (GI) Tract Origin
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract.
Read the detailed description
OBJECTIVES:
- Determine whether immunization with carcinoembryonic antigen (CEA) peptide 1-6D (CAP 1-6D) emulsified in Montanide ISA-51 adjuvant or dissolved in sargramostim (GM-CSF) can generate CAP 1-6D-specific T cells in patients with CEA-producing adenocarcinomas of gastrointestinal tract origin.
- Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against CEA-expressing tumors in these patients.
- Determine whether this vaccine can produce antitumor responses in these patients.
- Determine the frequency and severity of toxic effects associated with this vaccine in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carcinoembryonic antigen peptide 1-6D (CAP 1-6D) emulsified in Montanide ISA-51 adjuvant subcutaneously on day 1.
- Arm II: Patients receive CAP 1-6D dissolved in sargramostim (GM-CSF) intradermally on day 1.
Treatment repeats in both arms every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then as necessary.
PROJECTED ACCRUAL: A total of 10-36 patients (5-18 per arm) will be accrued for this study within 36 months.
- Conditions
- Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer
- Being tested
- carcinoembryonic antigen peptide 1-6D, incomplete Freund's adjuvant, sargramostim
- Keywords
- stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carcinoembryonic antigen peptide 1-6DBiological
incomplete Freund's adjuvantBiological
sargramostimBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of CAP 1-6D T cells
Production of cytotoxic T cells
Antitumor response
Frequency and severity of toxic effects
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 startJul 2002
- Primary completionJul 2006
- Study completionJul 2006
Why it stopped: Administratively Terminated
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.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert P. Whitehead, MD, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012246
- Sponsor's protocol ID
- CDR0000068497
- Other IDs
- UTMB-00-297, NCI-931
- Status last verified
- May 2013
- First submitted
- 3 Mar 2001
- Last updated
- 16 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Of Vaccination With The Carcinoembryonic Antigen (CEA) Peptide Cap 1-6D With Montanide ISA 51 Adjuvant Or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) In HLA-A2+ Patients With CEA Producing Adenocarcinomas Of Gastrointestinal (GI) Tract Origin
- ClinicalTrials.gov ID
- NCT00012246
- Acronym / sponsor ID
- CDR0000068497
- Conditions
- Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer
- Keywords
- stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage II pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (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 may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract.
Detailed description
OBJECTIVES:
- Determine whether immunization with carcinoembryonic antigen (CEA) peptide 1-6D (CAP 1-6D) emulsified in Montanide ISA-51 adjuvant or dissolved in sargramostim (GM-CSF) can generate CAP 1-6D-specific T cells in patients with CEA-producing adenocarcinomas of gastrointestinal tract origin.
- Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against CEA-expressing tumors in these patients.
- Determine whether this vaccine can produce antitumor responses in these patients.
- Determine the frequency and severity of toxic effects associated with this vaccine in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carcinoembryonic antigen peptide 1-6D (CAP 1-6D) emulsified in Montanide ISA-51 adjuvant subcutaneously on day 1.
- Arm II: Patients receive CAP 1-6D dissolved in sargramostim (GM-CSF) intradermally on day 1.
Treatment repeats in both arms every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then as necessary.
PROJECTED ACCRUAL: A total of 10-36 patients (5-18 per arm) will be accrued for this study within 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| carcinoembryonic antigen peptide 1-6D | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| sargramostim | Biological | – |
Primary outcome
Production of CAP 1-6D T cells
Production of cytotoxic T cells
Antitumor response
Frequency and severity of toxic effects
Results and safety
The study was stopped early (reason given: Administratively Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
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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.
Robert P. Whitehead, MD study chair
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carcinoembryonic antigen peptide 1-6D, incomplete Freund's adjuvant and sargramostim in people with Colorectal Cancer and Esophageal Cancer, run by The University of Texas Medical Branch, Galveston 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 16 May 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Administratively Terminated). 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?
Production of CAP 1-6D T cells. The study lists 4 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 16 May 2013.