Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Pembrolizumab

Imiquimod

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

* Epicutaneous cryoimmunotherapy treatments (6 total) during weeks 1-15 (every 2 weeks for the first 2 treatments, then every 3 weeks until week 15)
* Topical imiquimod will be applied 5 days per week (5 days on, 2 days off from weeks 1-15)
* Pembrolizumab will be given every 3 weeks for a minimum of 4 cycles starting at Week 3 until disease progression or unacceptable toxicity.
* Intra-lesional GM-CSF 250 mcg every 2 weeks x 2 doses then every 3 weeks for 3 doses

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.

Epicutaneous cryoimmunotherapy

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).

Topical imiquimod

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

* 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.

Dermatologic Quality of Life Index

* 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

Functional Assessment of Cancer Therapy

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

Intra-lesional GM-CSF

-Device used to give the cryoimmunotherapy

Cry-AC

-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.

Cutaneous tumor biopsy

Peripheral blood draw for research

Mateusz Opyrchal, M.D.

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.

Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

Phase IB Pilot Study of Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

-NCI Common terminology criteria for adverse events (CTCAE v5.0) will be used to grade toxicities

* For patients who present with discrete measurable lesions
* ORR = number of patients who achieve CR or PR divided by the total number response-evaluable patients
* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

* Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
* PFS is defined from date on treatment to the earliest date of progression, death, or last follow-up and progression or death are events of interest for PFS.

Merck Sharp & Dohme LLC

Washington University School of Medicine

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Anxiety Disorders

Depressive Disorder

Carcinoma

Carcinoma, Non-Small-Cell Lung

Depression

Gastrointestinal Neoplasms

Digestive System Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Diseases

Quality of Life

See methods below - standard strength and endurance training

See methods below - medical QiGong therapy session

The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy. This exercise program is supervised and consists of cardio-vascular and resistance training exercises. Participants are asked to refrain from practicing Qigong during this 6 week period.

Standard Exercise

Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks. Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation. Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.

Qigong Exercise

Thomas Jagoe, MD, PhD

Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.

Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy

Peer-reviewed manuscripts and conference proceedings

Depression and anxiety will be measured using the Hospital Anxiety Depression Scale (HADS); The HADS is a 14-item self-rated questionnaire, consisting of two 7-item subscales. It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress). The HADS will be administered within 2 weeks of completing each exercise program.

The general version of the Functional Assessment of Cancer Therapy scale (FACT-G) will be used to measure Quality of Life (QoL) after completion of each 6 week exercise program. This questionnaire consists of 4 subscales: Physical well-being (PWB), Social well-being (SWB), Emotional well-being (EWB) and Functional well-being (FWB). A change of 4 points on the total FACT score is regarded as clinically significant.

Functional capcity will be measured using the Simmonds Functional Assessment (SFA) within 2 weeks of finishing each 6-week exercise program. This tool consists of eight items: putting on a sock, tying a belt, putting coins in a cup, reaching forward, repeated reach up (3 times), repeated sit to stand (2 times), speed walk for 50 feet, and walking for 6 minutes. Patient satisfaction will be measured by asking all participants to answer a two item questionnaire with a 10-point visual analog scale response option.

Symptoms commonly reported by lung and GI cancer patients will be measured using the Edmonton Symptom Assessment Scale (ESAS). The ESAS is a 12-item patient rated symptom questionnaire scored using a 10-point visual analogue scale. The ESAS will be administered within 2 weeks of completing each 6-week exercise program.

Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer	NCT03982004	Metastatic Brea...	Epicutaneous cr... Topical imiquim... Pembrolizumab Dermatologic Qu... Functional Asse... Intra-lesional ... Cry-AC Cutaneous tumor... Peripheral bloo...	18 Years -	Washington University School of Medicine
Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer	NCT03982004	Metastatic Brea...	Epicutaneous cr... Topical imiquim... Pembrolizumab Dermatologic Qu... Functional Asse... Intra-lesional ... Cry-AC Cutaneous tumor... Peripheral bloo...	18 Years -	Washington University School of Medicine
Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer	NCT03982004	Metastatic Brea...	Epicutaneous cr... Topical imiquim... Pembrolizumab Dermatologic Qu... Functional Asse... Intra-lesional ... Cry-AC Cutaneous tumor... Peripheral bloo...	18 Years -	Washington University School of Medicine
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy	NCT01374100	Carcinoma, Non-... Cancer of the G...	Standard Exerci... Qigong Exercise	18 Years -	McGill University

Spots Global Cancer Trial Database for functional assessment of cancer therapy