Clinical trial NCT04875728: The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
Official title: Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Clinical Stage I Cutaneous Melanoma AJCC v8
Clinical Stage IA Cutaneous Melanoma AJCC v8
Clinical Stage IB Cutaneous Melanoma AJCC v8
Clinical Stage II Cutaneous Melanoma AJCC v8
Clinical Stage IIA Cutaneous Melanoma AJCC v8
Clinical Stage IIB Cutaneous Melanoma AJCC v8
Clinical Stage IIC Cutaneous Melanoma AJCC v8
Pathologic Stage I Cutaneous Melanoma AJCC v8
Pathologic Stage IA Cutaneous Melanoma AJCC v8
Pathologic Stage IB Cutaneous Melanoma AJCC v8
Pathologic Stage II Cutaneous Melanoma AJCC v8
Pathologic Stage IIA Cutaneous Melanoma AJCC v8
Pathologic Stage IIB Cutaneous Melanoma AJCC v8
Pathologic Stage IIC Cutaneous Melanoma AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.

SECONDARY OBJECTIVES:

I. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.

II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.

ARM B: Patients undergo standard of care surgical resection.

After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.

Eligibility criteria: Inclusion Criteria:

* Adult subjects with early stage melanoma (stage I-II)
* Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
* Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

* Use of antibiotics within the three months prior to surgery
* Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics
* Presence of an infection at the time of surgery
* Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)
* Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
* American Society of Anesthesiologists (ASA) grade \> IV
* Refusal to participate in the study
* Patients who are pregnant will not be included in this study

Primary outcomes:
measure: Change in microbiome alpha diversity
timeFrame: Baseline up to 2 weeks post-surgery
Secondary outcomes:
measure: Change in relative abundance of microbes
timeFrame: Baseline, at 2 weeks post-surgery, and 3 months post-surgery
measure: Change in microbiome diversity
timeFrame: Baseline up to 3 months post-surgery
measure: Wound (surgical site) infection rate
timeFrame: Up to 3 months post-surgery
measure: Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines
timeFrame: Up to 3 months post-surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Emily Z Keung
role: PRINCIPAL_INVESTIGATOR
References: