Pancreatic CancerEarly Phase 1NCT00364364
Safety Study to Determine the Appropriate Dose of Antibody Against Tumor Cells to Best Target Patients With Pancreatic Cancer.
A Early Phase 1 study testing Radiolabeled humanized PAM4 IgG in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This no treatment research study is being done to find a safe and an appropriate dose of antibody (protein) against tumor cells to best target the cancer in people with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Radiolabeled humanized PAM4 IgG
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must either have a histologic or cytological diagnosis of pancreatic cancer or a high clinical suspicion of pancreatic cancer.
- Patients must be 21 years of age.
- Patients must have measurable disease by CT scan.
- Patients must be at least 4 weeks beyond any major surgery.
- Patients must be at least 4 weeks beyond any chemotherapy or radiation therapy and must have recovered from treatment-induced toxicity.
- Patients must have a performance status of 70% or greater on the Karnofsky Scale and a minimal life expectancy of 3 months.
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- Patients must not have severe anorexia, nausea or vomiting, and no signs of intestinal obstruction.
- Patients must have a serum creatinine that is < 1.5 x the Institutional Upper Limit of Normal (IULN).
- AST/ALT < 2 times the IULN; serum bilirubin < 3 x IULN.
- WBC 3000/mm3, a granulocyte count 1500/mm3, and a platelet count 100,000/mm3.
- Patients must sign an informed consent, and be mentally responsible. There will be no discrimination based on race, creed, or ethnic background.
- Patients must be able to return to an approved study site for the scheduled follow-up procedures.
Who cannot join
- A.Subjects with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study. These include, but are not restricted to
- Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
- Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
- Subjects who have signs of intestinal obstruction.
- Subjects who are pregnant are excluded. D. Subjects who have a measurable antibody response to hPAM4 in their pre-study sample or who are proven allergic upon testing with the agent.
- Patients who are known to have HIV.
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- Patients who have a known history of Hepatitis B or C or any other serious liver abnormality will be excluded from enrollment.
- Prisoners or other institutionalized persons.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Institution, Dept of Radiology and Radiological Science
Baltimore, Maryland, 21287
About this study
Official title: Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
This no treatment research study is being done to find a safe and an appropriate dose of antibody (protein) against tumor cells to best target the cancer in people with pancreatic cancer. To do this, this no-treatment research study will compare two doses of an antibody called hPAM4 IgG when combined with a radioactive element, Indium-111.
Read the detailed description
This is an open-label, single-center, non-randomized, single-arm, pilot imaging study to determine the pharmacokinetics, biodistribution, and tumor targeting of an indium-111 (111In)-labeled, humanized anti-MUC1 antibody, designated hPAM4 IgG1 in patients with known pancreatic cancer. The primary objective of this trial is to examine how changing the protein dose will affect these parameters with the intent to determine if a single protein dose can be selected to optimize tumor targeting. It is expected that these data will aid in the selection of an appropriate protein dose to be used in a Phase I therapy trial with yttrium-90 (90Y)-labeled hPAM4 IgG. The secondary objective is to monitor safety.
Pharmacokinetics, biodistribution, tumor targeting, and dosimetry (modeling for 90Y) will be assessed against clinical parameters, such as pre-study PAM4-reactive MUC-1 antigen in the serum, tumor size, location, histopathology, immunohistology, and if possible, antigen content by extraction of tumor sample.
- Conditions
- Pancreatic Cancer
- Being tested
- Radiolabeled humanized PAM4 IgG
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabeled humanized PAM4 IgGDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the pharmacokinetics and tumor targeting of 111In-DOTA-hPAM4 anti-MUC-1 IgG given intravenously to patients with known or a suspicion of primary or recurrent pancreatic cancer.
An examination of how the pharmacokinetics and tumor targeting are affected by the amount of hPAM4 IgG administered.
Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.
For patients who undergo surgery after the 111In-hPAM4 study, targeting will be correlated against surgical findings.
Secondary outcomes (5)
Correlate tumor targeting, when feasible, with the following:Immunohistology using the hPAM4 antibody
Histology,Serum antigen content
Determine normal organ and, whenever possible, tumor dosimetry for 90Y-hPAM4 IgG based on the distribution and tumor targeting of 111In-hPAM4-IgG.
Monitor the development of antibody formation to the hPAM4, when feasible.
Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Loss of funding
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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Wahl, MD, Principal investigator, Johns Hopkins Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364364
- Sponsor's protocol ID
- J0473
- Other IDs
- CA098488, 05-02-07-05, C-062B-03
- Status last verified
- Dec 2008
- First submitted
- 14 Aug 2006
- Last updated
- 18 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
- ClinicalTrials.gov ID
- NCT00364364
- Acronym / sponsor ID
- J0473
- Conditions
- Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Aug 2006 (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.
This no treatment research study is being done to find a safe and an appropriate dose of antibody (protein) against tumor cells to best target the cancer in people with pancreatic cancer. To do this, this no-treatment research study will compare two doses of an antibody called hPAM4 IgG when combined with a radioactive element, Indium-111.
Detailed description
This is an open-label, single-center, non-randomized, single-arm, pilot imaging study to determine the pharmacokinetics, biodistribution, and tumor targeting of an indium-111 (111In)-labeled, humanized anti-MUC1 antibody, designated hPAM4 IgG1 in patients with known pancreatic cancer. The primary objective of this trial is to examine how changing the protein dose will affect these parameters with the intent to determine if a single protein dose can be selected to optimize tumor targeting. It is expected that these data will aid in the selection of an appropriate protein dose to be used in a Phase I therapy trial with yttrium-90 (90Y)-labeled hPAM4 IgG. The secondary objective is to monitor safety.
Pharmacokinetics, biodistribution, tumor targeting, and dosimetry (modeling for 90Y) will be assessed against clinical parameters, such as pre-study PAM4-reactive MUC-1 antigen in the serum, tumor size, location, histopathology, immunohistology, and if possible, antigen content by extraction of tumor sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All patients must either have a histologic or cytological diagnosis of pancreatic cancer or a high clinical suspicion of pancreatic cancer.
- Patients must be 21 years of age.
- Patients must have measurable disease by CT scan.
- Patients must be at least 4 weeks beyond any major surgery.
- Patients must be at least 4 weeks beyond any chemotherapy or radiation therapy and must have recovered from treatment-induced toxicity.
Key exclusion criteria (9 listed)
- A.Subjects with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study. These include, but are not restricted to
- Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
- Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
- Subjects who have signs of intestinal obstruction.
- Subjects who are pregnant are excluded. D. Subjects who have a measurable antibody response to hPAM4 in their pre-study sample or who are proven allergic upon testing with the agent.
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 |
|---|---|---|
| Radiolabeled humanized PAM4 IgG | Drug | – |
Primary outcome
Examine the pharmacokinetics and tumor targeting of 111In-DOTA-hPAM4 anti-MUC-1 IgG given intravenously to patients with known or a suspicion of primary or recurrent pancreatic cancer.
An examination of how the pharmacokinetics and tumor targeting are affected by the amount of hPAM4 IgG administered.
Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.
For patients who undergo surgery after the 111In-hPAM4 study, targeting will be correlated against surgical findings.
5 secondary outcomes
Correlate tumor targeting, when feasible, with the following:Immunohistology using the hPAM4 antibody
Histology,Serum antigen content
Determine normal organ and, whenever possible, tumor dosimetry for 90Y-hPAM4 IgG based on the distribution and tumor targeting of 111In-hPAM4-IgG.
Monitor the development of antibody formation to the hPAM4, when feasible.
Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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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.
Richard Wahl, MD principal investigator
Johns Hopkins Institution
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 Radiolabeled humanized PAM4 IgG in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jan 2019. 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: Loss of funding). 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?
Examine the pharmacokinetics and tumor targeting of 111In-DOTA-hPAM4 anti-MUC-1 IgG given intravenously to patients with known or a suspicion of primary or recurrent pancreatic cancer.. 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 18 Jan 2019.