This phase I trial studies the side effects and best dose of micro needle array-doxorubicin (MNA-D) in treating patients with stages IA or IB cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. MNA-D are small adhesive-like patches loaded with doxorubicin. These patches have pointy ends of microscopic size and after sticking on the skin, tiny prickles from the micro-needle array may bring drug into the lymphoma spot. MNA-D may enable direct and specific delivery of chemotherapy to the tumor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02192021.
PRIMARY OBJECTIVES:
I. To evaluate the safety of escalating, low doses (25-200 ug) of doxorubicin delivered directly and specifically into cutaneous T-cell lymphoma (CTCL) lesions using the MNA-D system.
SECONDARY OBJECTIVES:
I. Evaluations of the pharmacokinetics and pharmacodynamics (PK/PD) of doxorubicin when delivered using the MNA-D system.
II. Evaluations of local, locoregional, and distant responses, biologic responses, and effects of treatment on the tumor microenvironment.
OUTLINE: This a phase I dose-escalation study.
Patients receive 3 micro needle array-doxorubicin patches over 20 minutes on days 0, 7, 14 and 21 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up to 4 weeks.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorOleg E Akilov
