NeoplasmsPhase 1NCT00095160
Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
A Phase 1 study testing 852A in people with Neoplasms, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- 852A
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jan 2006
- 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
Who may be able to join
- Have solid organ tumors refractory to currently available treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Have a life expectancy of 4 months
- Have normal organ and bone marrow function
Who cannot join
- Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier.
- Use of investigational agent in the 4 weeks prior to 1st dose of the study drug
- Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose
- Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
- Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
- Have a history of disease requiring ongoing steroid treatment
Show all 10Show fewer
- Have a history of seizure disorders uncontrolled on medication
- Have a history of clinically significant coagulation or bleeding disorders or abnormalities
- Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.
- Are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors
Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.
- Conditions
- Neoplasms
- Being tested
- 852A
- Keywords
- Solid Organ Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
852ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Pharmacokinetics
Secondary outcomes (1)
Tumor Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2004 (estimated)
- Study startOct 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Jeffrey Miller, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095160
- Sponsor's protocol ID
- 2003LS039
- Other IDs
- 1493-852A
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2004
- Last updated
- 29 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors
- ClinicalTrials.gov ID
- NCT00095160
- Acronym / sponsor ID
- 2003LS039
- Conditions
- Neoplasms
- Keywords
- Solid Organ Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 2 Nov 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.
Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
Key inclusion criteria (4 listed)
- Have solid organ tumors refractory to currently available treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Have a life expectancy of 4 months
- Have normal organ and bone marrow function
Key exclusion criteria (10 listed)
- Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier.
- Use of investigational agent in the 4 weeks prior to 1st dose of the study drug
- Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose
- Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
- Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
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 |
|---|---|---|
| 852A | Drug | – |
Primary outcome
Safety and Pharmacokinetics
1 secondary outcome
Tumor Response
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 29 Nov 2017.
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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.
Jeffrey Miller, MD principal investigator
Masonic Cancer Center, University of Minnesota
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 852A in people with Neoplasms, run by Masonic Cancer Center, University of Minnesota 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 4 inclusion and 10 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 29 Nov 2017. 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 and Pharmacokinetics. 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 29 Nov 2017.