Status:
COMPLETED
Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)
Lead Sponsor:
Falo, Louis, MD
Conditions:
Cutaneous T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will kill tumor cells locally and alter the tumor microenvironment to induce durable systemic tumor-specific imm...
Detailed Description
This study will evaluate a novel approach to the treatment of patches and plaques in the skin of patients diagnosed with cutaneous t-cell lymphoma utilizing a dissolvable microneedle array (MNA) deliv...
Eligibility Criteria
Inclusion
- Diagnosis of Cutaneous T-cell Lymphoma (CTCL) based upon a skin biopsy diagnostic of atypical epidermotropism of folliculocentric or epidermotropic T-cells.
- Current stage of IA or IB.
- Expected survival of greater than or equal to12 months.
- Not be on any other investigational device/drug treatment.
- Have a sufficient number (i.e., n=4 for first dose cohort in Initial Safety Evaluation; n=3 for remainder of subjects) and surface area (\> 5 cm2) of CTCL patches or plaques for Micro needle array-Doxorubicin (MNA-D) and Micro needle array (MNA) application.
- Willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.
- Have the following initial and subsequent pretreatment laboratory parameters: granulocytes ≥2,000/mm3; platelets \>50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT, , LDH, Alk phos ≤3X the ULN.Subjects must be ³ 18 years of age and must be able to understand the written informed consent/assent document.
- Have no evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics before beginning treatment.
- Not receive any other treatment for CTCL except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
- Willing to discontinue concomitant medications for CTCL for the duration of their study participation, including: high dose topical steroids - 2 week washout; oral steroids above 10 mg - 3 week washout; Psoralen + Ultraviolet A light (PUVA) or ultraviolet B light (UVB) (including sunbathing, tanning beds, etc.) - 2 week washout; extracorporeal photopheresis - 2 week washout; Electron Beam - 2 weeks washout; chemotherapeutic agents - 3 week washout; bexarotene capsules or other oral biologics - 2 week washout; and topical nitrogen mustard - 2 week washout.
- May re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion/exclusion criteria are met.
Exclusion
- Uncontrolled pain.
- Known history of autoimmune disease; or active HIV, HTLV-1, and/or hepatitis infection.
- Pregnant or lactating.
- Have sensitivity to drugs that provide local anesthesia.
- Have active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.
Key Trial Info
Start Date :
March 9 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02192021
Start Date
March 9 2016
End Date
December 9 2020
Last Update
August 9 2024
Active Locations (1)
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1
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213