Cathepsin Activatable Fluorescent Probe (LUM015)
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|ClinicalTrials.gov Identifier: NCT01626066|
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : December 9, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Soft Tissue Sarcoma Breast Cancer||Drug: LUM015||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2015|
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
LUM015 assigned dose given once by IV push
- Dose of LUM015 in mg [ Time Frame: 24 hours ]Dose of LUM015 in mg that is tolerated and labels tumors
- 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 ]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.
- To analyze cathepsin protease expression in tumors. [ Time Frame: 2 Years ]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.
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|Ages Eligible for Study:||18 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626066
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Brian Brigman, MD||Duke University|
|Responsible Party:||David Kirsch, Associate Professor of Radiation Oncology, Duke University|
|Other Study ID Numbers:||
|First Posted:||June 22, 2012 Key Record Dates|
|Last Update Posted:||December 9, 2015|
|Last Verified:||December 2015|
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type