Pancreatic CancerPhase 1NCT00997958
Study of CellCept for Advanced Pancreatic Cancer
A Phase 1 study testing Mycophenolate mofetil in people with Pancreatic Cancer, run by Columbia University at 1 site in United States.
Trial summary
Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to prevent the body's immune system from attacking transplanted organs. It has never been studied in patients with pancreatic cancer but some preliminary studies have shown that it may antagonize tumor growth. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jan 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of pancreas.
- Disease stage IV, locally advanced and/or metastatic.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scan.
- The following lesions conventionally are not considered measurable:
- CNS lesions
- Blastic or lytic bone lesions (which will be documented and followed)
Show all 36Show fewer
- Radiated lesions unless progression after RT is documented
- Ineligible for other high priority national or institutional studies.
- Prior therapy allowed:
- Chemotherapy (at least one prior regimen)
- > 3 weeks since last chemotherapy
- > 3 weeks since surgery
- ≥ 4 weeks since RT
- Non pregnant, non lactating women with a negative serum α-HCG test within one week of starting the study, AND
- Must be willing to consent to the use of two forms of contraception (at least one barrier) if of childbearing potential while on trial and six weeks after CellCept has been stopped.
- Clinical Parameters:
- Life expectancy ≥ 3 months
- Age 18 to 70 years
- Brain CT or MRI no visible metastases
- Performance status 0-2 (ECOG- see appendix B)
- HIV negative or never tested
- Required initial laboratory data:
- Normal
- White cell count ≥3000 cells / μl
- Platelet count ≥100,000 platelets / μl
- BUN ≤1.5 x normal 20 mg/dl
- Creatinine ≤1.5 x normal 1.0 mg/dl
- Total Bilirubin ≤3.0 mg/dl
- AST, ALT ≤3.0 x normal 38 U/L
- Alkaline Phosphatase ≤3.0 x normal 96 U/L
- Albumin ≥2.5 g/dl
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, adverse effects, risks, and discomforts.
- Prior malignancy in last 5 years: The cancer must be curatively treated carcinoma in situ of the cervix or skin cancer.
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Absence of concurrent treatment with cholestyramine, acyclovir, cyclosporine, or antacids with magnesium or aluminum hydroxides because of their effects on drug metabolism and serum levels of MPA.
- Absence of active serious digestive system disease as defined at the discretion of the Principal Investigator.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Phase I Study of CellCept for Advanced Pancreatic Cancer
Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to prevent the body's immune system from attacking transplanted organs. It has never been studied in patients with pancreatic cancer but some preliminary studies have shown that it may antagonize tumor growth. The goals of this study are to find out how much of this drug can safely be taken by patients with advanced pancreatic cancer and to assess the variation of the level of the drug in the blood. Patients will take the drug twice a day at a given dose and the safety of the drug will be monitored through patient symptoms and blood tests. The disease burden will be assessed by radiographic studies at the beginning and end of the study. The patient will take the drug for a total of eight weeks.
Read the detailed description
Mycophenolate Mofetil (CellCept) is a prodrug whose active metabolite, mycophenolic acid (MPA), acts as an immune suppressant by inhibiting de novo guanosine synthesis. CellCept is FDA approved to prevent rejection of transplanted organs. It is well tolerated, orally dosed, and has some known antitumor effects. It has never been studied in pancreatic cancer and the maximum tolerated dose is not known. In vitro studies in our lab with human pancreatic cancer lines found that MPA was a potent inhibitor of pancreatic cancer cell growth and induced apoptosis. The objectives of this study are to identify the maximum tolerated dose of CellCept in patients with advanced pancreatic cancer that have failed at least two prior chemotherapy regimens and assess its pharmacokinetics.
- Conditions
- Pancreatic Cancer
- Being tested
- Mycophenolate mofetil
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation increasing successively from 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, and 5.0 grams p.o. bid.
Each patient will be treated for eight weeks (56 days).
| Study group | Role | What they receive |
|---|---|---|
| CellCept | Experimental | Administered in tablet form twice daily one hour after eating. Receives: Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2004
- Primary completionOct 2007
- Study completionJan 2009
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 Columbia 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 (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Fine, Columbia University
- Investigators
- Robert L Fine, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997958
- Sponsor's protocol ID
- AAAA1127
- Status last verified
- Apr 2014
- First submitted
- 14 Oct 2009
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of CellCept for Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00997958
- Acronym / sponsor ID
- AAAA1127
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Oct 2009 (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.
Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to prevent the body's immune system from attacking transplanted organs. It has never been studied in patients with pancreatic cancer but some preliminary studies have shown that it may antagonize tumor growth. The goals of this study are to find out how much of this drug can safely be taken by patients with advanced pancreatic cancer and to assess the variation of the level of the drug in the blood. Patients will take the drug twice a day at a given dose and the safety of the drug will be monitored through patient symptoms and blood tests. The disease burden will be assessed by radiographic studies at the beginning and end of the study. The patient will take the drug for a total of eight weeks.
Detailed description
Mycophenolate Mofetil (CellCept) is a prodrug whose active metabolite, mycophenolic acid (MPA), acts as an immune suppressant by inhibiting de novo guanosine synthesis. CellCept is FDA approved to prevent rejection of transplanted organs. It is well tolerated, orally dosed, and has some known antitumor effects. It has never been studied in pancreatic cancer and the maximum tolerated dose is not known. In vitro studies in our lab with human pancreatic cancer lines found that MPA was a potent inhibitor of pancreatic cancer cell growth and induced apoptosis. The objectives of this study are to identify the maximum tolerated dose of CellCept in patients with advanced pancreatic cancer that have failed at least two prior chemotherapy regimens and assess its pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CellCept | Experimental | Drug: Mycophenolate mofetilAdministered in tablet form twice daily one hour after eating. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Histologically confirmed adenocarcinoma of pancreas.
- Disease stage IV, locally advanced and/or metastatic.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scan.
- The following lesions conventionally are not considered measurable:
- Ineligible for other high priority national or institutional studies.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mycophenolate mofetilDose escalation increasing successively from 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, and 5.0 grams p.o. bid. Each patient will be treated for eight weeks (56 days). | Drug | CellCept |
Primary outcome
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer
Time frame: 8 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 25 Apr 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.
Robert L Fine, MD principal investigator
Columbia 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 Mycophenolate mofetil in people with Pancreatic Cancer, run by Columbia 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 36 inclusion and 0 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 25 Apr 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?
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer (time frame: 8 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 25 Apr 2014.