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Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

NCT03982004 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-06-21

No results posted yet for this study

Summary

The purpose of this research study is to look at the safety and side effects of combining the drug pembrolizumab with imiquimod, GM-CSF, and cryotherapy to treat breast cancer that includes skin lesions.

Conditions

Interventions

DEVICE

Epicutaneous cryoimmunotherapy

Epicutaneous cryoimmunotherapy (EC) treatment includes liquid nitrogen cryotherapy applied for 10 seconds x 2 freeze-thaw cycles. Four treatment areas will be chosen at each treatment.

DRUG

Topical imiquimod

Patients will apply the cream directly over the treatment areas and can use up to one packet per day (covers approximately 5 cm x 5 cm).

DRUG

Pembrolizumab

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion

OTHER

Dermatologic Quality of Life Index

* 10 questions about how much skin problems has affected the participant's life over the past week * The scoring of each question is as follows: very much = 3, a lot = 2, a little = 1, not at all = 0, not relevant = 0, and question #7 'prevented work or studying' = 3 * The DLQI is calculated by summing the score of each question resulting in a max of 30 and min of 0. The higher the score, the more quality of life is impaired.

OTHER

Functional Assessment of Cancer Therapy

* 5 subscales (physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns) * Answers ranging from 0=Not at all to 4 = very much * Each item is rated on a 5-point Likert scale. * The higher the score on the social/family well-being and functional well-being indicate higher quality of life * The lower the score on physical well-being, emotional well-being, and additional concerns indicate higher quality of life

DRUG

Intra-lesional GM-CSF

250 mcg every 2 weeks x 3 doses then every 3 weeks for 3 doses

DEVICE

Cry-AC

-Device used to give the cryoimmunotherapy

PROCEDURE

Cutaneous tumor biopsy

-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.

PROCEDURE

Peripheral blood draw for research

-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.

Sponsors & Collaborators

Principal Investigators

  • Mateusz Opyrchal, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-03-03
Completion
2021-03-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982004 on ClinicalTrials.gov