Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03789864 |
| Other study ID # |
1804939675 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2019 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a single-arm, non-randomized feasibility study designed to find out if the laser
light-based imaging test called Biodynamic imaging (BDI) can correctly predict the cutaneous
T-cell lymphoma mycosis fungoides (MF) cancer response to chemotherapy treatment. The primary
objective is to develop phenotypic profiles of response and non-response to gemcitabine,
given at a standard-of-care dose and schedule. A secondary objective is to perform a
cross-species analysis of phenotypic responses of human and canine mycosis fungoides to
gemcitabine using biodynamic imaging. The study will seek to enroll 10 patients with MF who
are planning to receive treatment with gemcitabine given at a standard-of-care (SOC) dose and
schedule at Indiana University Simon Cancer Center (IUSCC). All subjects will undergo
standardized staging tests, with tumor stage defined according to established guidelines. For
the study, three 6-mm x 4-mm dermal punch biopsies from one or more target lesions will be
collected prior to treatment initiation and sent to Purdue University researchers for BDI.
Objective response for tumor samples treated with gemcitabine in the laboratory will be
assessed. Patients with an objective response of complete response (CR) or partial response
(PR) that persists during the first 2 treatment cycles will be considered to have responsive
cancers, while those failing to meet these criteria will be considered to have resistant
cancers. All patients will be considered off-study after completing cycle 2. Accrual is
expected to last approximately 24 months.
Description:
The purpose of this study is to find out if the laser light-based imaging test called
Biodynamic imaging (BDI) can correctly predict the response of cutaneous T-cell lymphoma
mycosis fungoides cancer to gemcitabine chemotherapy treatment. No untested medications or
devices will be used in this study. Subject's response to chemotherapy will be measured after
the first and second months (cycles) of chemotherapy; therefore, the BDI test cannot be used
to predict whether subject will respond to the treatment or not in advance, and treatment
decisions will not be made using any of the information obtained through this study.
As part of routine treatment for mycosis fungoides, subjects who are being referred for
routine treatment with gemcitabine chemotherapy given at a standard-of-care (SOC) dose and
schedule at the Indiana University Simon Cancer Center (IUSCC) will be enrolled.
Standard-of-care Gemcitabine is given intravenously (i.e. in the vein as in infusion) 3 times
every 28 days on days 1, 8, and 15. Each 28 day period is called a cycle. Gemcitabine
infusion generally lasts 30 minutes. If subject agrees to participate in this study,
researchers would document representative skin lesions by color photography including a ruler
to estimate the size of the lesion, and objectively calculate disease burden by using the
modified Severity Weighted Assessment Tool (mSWAT). Researchers would also collect samples of
your tumor tissue before subject starts chemotherapy to be used for the BDI testing in the
laboratory by the Purdue University collaborative research team. The BDI testing will be done
at baseline on day of collection. We would also evaluate subject's response to treatment
after the 1st and 2nd cycles completion through PET/CT or CT scans, skin examinations, and/or
laboratory tests depending upon subject's disease. The following is a list of what subjects
can expect at each of their study visits.
Pre-treatment: Screening
1. Subject Consenting - approximately 30 - 40 minutes
2. Collect Demographic information, Medical History - approximately 5- 10 minutes
3. Physical Exam/performance status: A physical exam will be performed by the doctor, and
the doctor will document subjects' overall health and how well subjects are able to
perform their activities of daily living.
4. Skin biopsy: One or more areas of subject's skin that has the cancer will be cleansed
with alcohol. The areas will be numbed by injecting a small amount of anesthesia in the
skin. As part of routine biopsy procedures in the Department of Dermatology, photographs
may be taken of the lesions/tumors that will be biopsied. When the areas of the skin are
numb, 3 samples of your skin about 4-mm deep (6-mm wide skin punch biopsies), will be
removed from one or more sites and sent for BDI testing. A small stitch will be placed
in each biopsy site. Subjects will be given sterile wound dressings and wound care
instructions including samples of petrolatum to allow subject to take care of the small
wounds. The stitches from the biopsy sites will be removed 10-14 days later.
5. Skin disease severity scoring: In order to determine the extent of subject's disease,
the physician will physically examine subject's skin.
Post-Enrollment
1. Laboratory tests: These tests are used to determine subject's fitness to undergo
treatment with gemcitabine and to determine extent of disease. These tests are
comprehensive metabolic panel (CMP), complete blood count (CBC), and peripheral blood
flow cytometry.
2. Scans: Positron emission tomography (PET)/computed tomography (CT) or CT scans of
subject's neck, chest, abdomen and pelvis will be done to determine extent of your
disease. A PET/CT scan from subject's skull to the base of subject's thighs may be done
depending upon subject's disease at the recommendation of subject's doctor.
All of these tests are done routinely in patients with the same disease being referred for
treatment with gemcitabine with the exception of skin biopsy and, if needed, flow cytometry
and radiological scans after the first round of chemotherapy, which are being done for
research purposes. Treatment End of Cycle 1/Before Cycle 2 (Approximately day 28 depending
upon whether subjects have any delays in treatment)
1. Physical exam: A routine physical exam will be performed by the doctor.
2. Skin disease severity scoring: The physician will physically examine subject's skin to
determine subject's response to chemotherapy at this time point.
3. Laboratory tests: Comprehensive metabolic panel (CMP) and complete blood count (CBC)
blood tests will be done as is routine for patients undergoing gemcitabine treatment;
however, peripheral blood flow cytometry may also be done depending upon the
researcher's assessment of subject's disease to determine subject's response to
chemotherapy at this time point.
4. CT scan: A CT scan may also be done depending upon the researcher's assessment of
subject's disease to determine subject's response to chemotherapy at this time point.
End of Cycle 2/Before Cycle 3 (Approximately day 56 depending upon whether subject have any
delays in treatment)
1. Physical exam: A routine physical exam will be performed by the doctor.
2. Skin disease severity scoring: The physician will physically examine subject's skin to
determine subject's response to chemotherapy at this time point.
3. Laboratory tests: Comprehensive metabolic panel (CMP) and complete blood count (CBC)
blood tests will be done as is routine for patients undergoing gemcitabine treatment;
however, peripheral blood flow cytometry may also be done depending upon the
researcher's assessment of subject's disease to determine subject's response to
chemotherapy at this time point.
4. CT scan: A CT scan may also be done depending upon the researcher's assessment of
subject's disease to determine subject's response to chemotherapy at this time point.
