Pancreatic CancerPhase 1NCT00008099
Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
A Phase 1 study testing MUC1 antigen/SB AS-2 in people with Pancreatic Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MUC1 antigen/SB AS-2
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Feb 2004
- 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 resected or locally advanced unresectable pancreatic cancer No metastases
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent glucocorticosteroids Radiotherapy: No prior radiotherapy Surgery: At least 3 weeks since prior resection of pancreatic cancer Other: No concurrent non-steroidal anti-inflammatory drugs (NSAIDs)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase I Dose Escalation Trial of a 100 aa Synthetic Mucin Peptide Admixed With SB-AS2 as Adjuvant in Locally Advanced and Resected Pancreatic Cancer
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer.
Read the detailed description
OBJECTIVES: I. Determine the safety and toxicity of vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable pancreatic cancer. II. Determine the maximum tolerated dose and/or recommended phase II dose of MUC-1 antigen in this patient population. III. Determine the qualitative and quantitative tumor response to this treatment in these patients. IV. Determine the disease-free survival in resected patients, progression-free survival in locally advanced unresectable patients, and overall survival in all patients receiving this treatment.
OUTLINE: This is a dose escalation study of MUC-1 antigen. Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1. Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 year after the last vaccination, patients without recurrent disease may receive booster vaccines annually. Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- MUC1 antigen/SB AS-2
- Keywords
- stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUC1 antigen/SB AS-2Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Recurrence
Measured: 1-2 years
Secondary outcomes (1)
Overall Survival
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2004 (estimated)
- Study startMay 1998
- Primary completionMar 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Herbert J. Zeh, III MD, FACS, University of Pittsburgh
- Investigators
- Ramesh K. Ramanathan, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008099
- Sponsor's protocol ID
- PCI-97-046
- Other IDs
- CDR0000068375, PCI-IRB-970871, NCI-G00-1888
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2001
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Trial of a 100 aa Synthetic Mucin Peptide Admixed With SB-AS2 as Adjuvant in Locally Advanced and Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00008099
- Acronym / sponsor ID
- PCI-97-046
- Conditions
- Pancreatic Cancer
- Keywords
- stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- Mar 2001 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 4 May 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 may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer.
Detailed description
OBJECTIVES: I. Determine the safety and toxicity of vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable pancreatic cancer. II. Determine the maximum tolerated dose and/or recommended phase II dose of MUC-1 antigen in this patient population. III. Determine the qualitative and quantitative tumor response to this treatment in these patients. IV. Determine the disease-free survival in resected patients, progression-free survival in locally advanced unresectable patients, and overall survival in all patients receiving this treatment.
OUTLINE: This is a dose escalation study of MUC-1 antigen. Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1. Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 year after the last vaccination, patients without recurrent disease may receive booster vaccines annually. Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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
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 |
|---|---|---|
| MUC1 antigen/SB AS-2 | Biological | – |
Primary outcome
Disease Recurrence
Time frame: 1-2 years
1 secondary outcome
Overall Survival
Time frame: 2-5 years
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 20 Jan 2016.
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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.
Ramesh K. Ramanathan, MD study chair
University of Pittsburgh
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 MUC1 antigen/SB AS-2 in people with Pancreatic Cancer, run by University of Pittsburgh 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 20 Jan 2016. 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?
Disease Recurrence (time frame: 1-2 years). 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 20 Jan 2016.