SarcomaPhase 1LUM015NCT01626066
Cathepsin Activatable Fluorescent Probe
A Phase 1 study testing LUM015 in people with Sarcoma and Soft Tissue Sarcoma, run by David Kirsch at 1 site in United States.
Trial summary
Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Sarcoma, Soft Tissue Sarcoma, Breast Cancer
- What is being tested?
- LUM015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2015
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy.
- Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size.
- Performance status of 0 or 1
- Able to read, understand and sign an informed consent form
- Must be able and willing to follow study procedures and instructions including a possible overnight stay before surgery
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- Otherwise healthy except for the diagnosis of cancer
- ALT, AST, and total bilirubin within 1.5x institutional upper normal limits; and alkaline phosphatase within 2.5x institutional upper normal limits
- Serum creatinine of 1.5 mg or less; creatinine clearance greater than 30 ml/min
- May have previously received pre-operative external beam radiation therapy for this sarcoma
Who cannot join
- Pregnant or lactating
- Prolonged QT interval: corrected QT interval (QTc) > 480 msec
- Insulin dependent diabetes
- History of anaphylactic reactions to any drug or contrast agent
- Asthma under medical management
- Uncontrolled high blood pressure
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- Severe, active co-morbidity
- Known substance addiction
- Sexually active and not willing/able to use medically acceptable forms of contraception.
- Obesity defined as BMI as body mass index greater than 35 kg/meter squared.
- Atopy or atopic syndrome
- Known AIDS
- Cannot have taken an investigational drug within 30 days of coming onto this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Breast Cancer
- Being tested
- LUM015
- Medical subject headings
- Sarcoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM015Drug
LUM015 assigned dose given once by IV push
| Study group | Role | What they receive |
|---|---|---|
| LUM015 | Experimental | Receive single dose of LUM015 through a vein in the arm the day prior to surgery Receives: Drug: LUM015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of LUM015 in mg
Dose of LUM015 in mg that is tolerated and labels tumors
Measured: 24 hours
Secondary outcomes (3)
Mean number of fluorescence counts per second per square centimeter
Measured: At time of surgery
To obtain PK/PD information regarding LUM015 when administered IV in patients.
The pharmacokinetic parameters to be measured will include: area under the curve (AUCt), maximum concentration (Cmax), time to maximum concentration (tmax) and first-order terminal (elimination) rate constant. Secondary (derived) parameters will include: terminal half-life (t1/2), clearance (CL), mean residence time (MRT), and apparent volume of distribution during the terminal phase (Vz). The distribution of these parameters will be described for each dose cohort separately; breast and sarcoma patients will be combined.
Measured: Two years
To analyze cathepsin protease expression in tumors.
Cathepsin expression in tumors, measured in arbitrary units by Real-Time PCR compared to adjacent normal tissue when available, will be assessed in sarcomas and breast tumors. For each tissue specimen the expression of cathepsin will be compared to the imaging signal. Scatterplots of cathepsin level against imaging signal will be made according to tissue type within each dose cohort.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Kirsch
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Sponsor-investigator, David Kirsch, Duke University
- Investigators
- Brian Brigman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626066
- Sponsor's protocol ID
- Pro00035444
- Acronym
- LUM015
- Status last verified
- Dec 2015
- First submitted
- 20 Jun 2012
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
- ClinicalTrials.gov ID
- NCT01626066
- Acronym / sponsor ID
- LUM015 / Pro00035444
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- David KirschUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Jun 2012 (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.
Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUM015 | Experimental | Drug: LUM015Receive single dose of LUM015 through a vein in the arm the day prior to surgery |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older
- Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy.
- Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size.
- Performance status of 0 or 1
- Able to read, understand and sign an informed consent form
Key exclusion criteria (13 listed)
- Pregnant or lactating
- Prolonged QT interval: corrected QT interval (QTc) > 480 msec
- Insulin dependent diabetes
- History of anaphylactic reactions to any drug or contrast agent
- Asthma under medical management
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 |
|---|---|---|
| LUM015LUM015 assigned dose given once by IV push | Drug | LUM015 |
Primary outcome
Dose of LUM015 in mg
Time frame: 24 hours
Dose of LUM015 in mg that is tolerated and labels tumors
3 secondary outcomes
Mean number of fluorescence counts per second per square centimeter
Time frame: At time of surgery
To obtain PK/PD information regarding LUM015 when administered IV in patients.
Time frame: Two years
To analyze cathepsin protease expression in tumors.
Time frame: 2 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 9 Dec 2015.
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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.
Brian Brigman, MD principal investigator
Duke 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 LUM015 in people with Sarcoma and Soft Tissue Sarcoma, run by David Kirsch 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 10 inclusion and 13 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 9 Dec 2015. 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?
Dose of LUM015 in mg (time frame: 24 hours). 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 9 Dec 2015.