Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC

ConditionCarcinoma, Squamous Cell

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMelissa Pugliano-Mauro

About this trial

This clinical trial proposes to evaluate a relatively unexplored approach to treatment of squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and specifically deliver drug to the tumor. For the proposed phase I clinical trial, the investigators will perform intralesional injections of a well characterized, potent chemotherapeutic agent 5-fluorouracil (5FU) with and without a topical application of 0.005% calcipotriene cream to kill topically accessible SCC cells. The goal of the study is to evaluate the safety profile and tolerability of intralesional-5FU with and without a concomitant topical calcipotriene and measure the clinical objective response rate (ORR) in treated lesions compared to untreated lesions 3 weeks after treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Biopsy-confirmed SCC more than 1.0 cm and less than 2.0 cm in diameter in the lower extremities, defined as the knees and below.

Subjects must have an expected survival of greater than or equal to12 months.

Subjects must not be on any other investigational device/drug treatment.

Subjects must to be 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.

Disqualifiers

Patients with any evidence of nodal (Nx) and/or metastatic disease including distant subcutaneous and/or lymph node metastases.

Patients with primary non-cutaneous SCC - such as nasopharyngeal SCC.

Patient with history of receiving organ transplantation.

Patients with history of iatrogenic systemic immunosuppression.

Trial design

Design model

Parallel

Treatments tested in this trial

5-fluorouracil
Drug
Intralesional injections of 50mg/ml over a 3 week period.
Calcipotriene
Drug
Topical application of .005% cream two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections..

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: Control GroupNo intervention 0 interventions

Group B: 5FU GroupExperimental treatment 1 intervention

Group C: 5FU + 0.005% Calcipotriene cream GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Determine number of subjects experiencing Dose Limiting Toxicity (DLT) higher than grade 2, as defined by CTCAE v. 4.0

To assess Dose Limiting Toxicities (DLT) of intralesional-5FU and intralesional 5FU combined with topical imiquimod in subjects after 3 weeks of treatment. Dose Limiting Toxicities (DLT) are defined as: Higher-than grade 2 hematologic or non-hematologic toxicity that is definitely, probably, or possibly related to intralesional 5FU administration and/or topical imiquimod application. The NCI common terminology criteria for adverse events (CTCAE) version 4.0 will be used. Based on the results of the previous studies on treating SCCs with 5FU injection or topical imiquimod, significant toxicities are not expected. Adverse reactions were limited to local site reactions such as treatment site pain, induration, erythema, edema. If a patient has a DLT, doses will be delayed if any Grade \>2 toxicities are not resolved to Grade 1 by the time of the next dose.

Time frame

84 days

Secondary outcomes

Asses clinical objective response rate

Measure reduction in tumor burden to assess clinical objective response rate (ORR) in treated lesions. Response will be evaluated using modified Composite Assessment of Index Lesion Severity (CAILS) criteria by bi-dimensional measurement.

Time frame

84 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Melissa Pugliano-Mauro

Lead sponsor

University of Pittsburgh

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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