An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays containing Doxorubicin (D-MNA) in Participants with Basal Cell Carcinoma (BCC)

This Study is
No Longer Enrolling

Description

The participant will be treated with microneedle arrays containing doxorubicin (D-MNA) or microneedle arrays containing placebo. The D-MNA or MNA-placebo is applied to the BCC lesion and secured to the skin with a self-adhesive bandage. The D-MNA is removed from the skin after 30 minutes. Each participant will receive three (3) weekly applications of the D-MNA unless a dose limiting toxicity (DLT) requires skipping or postponement of an application. The investigational product is chemotherapeutic agent doxorubicin (25 ug, 50 ug, 100 ug, or 200 ug) delivered to specific skin strata by a novel delivery system, MNA or placebo delivered to specific skin strata by MNA.

Details
Age

Adult

Eligibility

5.1 INCLUSION CRITERIA The participant must meet all the following criteria to be eligible to participate in this study: 1. Adult males and females, 18+ years in general good health as assessed by the investigator. 2. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit 3. Primary BCC (i.e., no previous treatment) 4. Lesion size ≥ 64 mm2 or 8 x 8 mm and ≤ 169 mm2 or 13 x 13 mm, i.e., the entire lesion must be covered by 13X13 mm area of the array containing the microneedles 5. Clinical laboratory results within the following ranges: a. granulocytes ≥2,000/mm3 b. platelets >50,000/mm3 c. serum creatinine ≤2X the upper limit of normal (ULN) d. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), alkaline phosphatase ≤3X the ULN. 6. Participant must have no other “clinically significant” abnormal findings in his/her medical history, physical examination or clinical laboratory test results as assessed by the investigator 7. Negative urine pregnancy at study entry for female of child bearing potential 8. Men and women of child-producing potential must agree to use adequate contraception according to standard instructions by the investigator until the completion of the study 9. Participant must to be willing to adhere to the instructions of the investigator and his or her research team 10. Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study 5.2 EXCLUSION CRITERIA A participant who meets any of the following criteria will be excluded from participation in this study: 1. Evidence of clinically significant, unstable medical conditions as assessed by the investigator 2. Excisional biopsy performed on the lesion to be treated in this study 3. Recent therapy(ies) to the BCC treatment area 4. Recurrent BCC (previously treated) at the site presented for treatment 5. BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant 6. Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose. 7. Participant with other active malignancies except for non-metastatic prostate cancer and carcinoma in situ of the skin and cervix 8. Participant with evidence of metastatic malignancies 9. Concomitant disease requiring systemic immunosuppressive treatment 10. Genetic skin cancer disorder, e.g., basal cell nevus syndrome 11. Participant is pregnant or breastfeeding 12. Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit 13. Existing condition or treatment within 3 months prior to the Screening Visit that may have impact on clinical outcome for the treatment of BCC or delay in wound healing from the elliptical excision

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Treatment

Locations

University of Colorado Hospital

Study ID

Protocol Number: 19-0035

More information available at ClinicalTrials.gov: NCT03646188

Categories

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