The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting

Phase 1

Conditions

Clinical Stage IIA Cutaneous Melanoma AJCC v8

Clinical Stage IB Cutaneous Melanoma AJCC v8

Pathologic Stage IA Cutaneous Melanoma AJCC v8

Clinical Stage IA Cutaneous Melanoma AJCC v8

Pathologic Stage IB Cutaneous Melanoma AJCC v8

Clinical Stage I Cutaneous Melanoma AJCC v8

Clinical Stage IIB Cutaneous Melanoma AJCC v8

Pathologic Stage IIC Cutaneous Melanoma AJCC v8

Pathologic Stage IIA Cutaneous Melanoma AJCC v8

Clinical Stage II Cutaneous Melanoma AJCC v8

Clinical Stage IIC Cutaneous Melanoma AJCC v8

Pathologic Stage II Cutaneous Melanoma AJCC v8

Pathologic Stage I Cutaneous Melanoma AJCC v8

Pathologic Stage IIB Cutaneous Melanoma AJCC v8

Treatments

Procedure: Resection

Drug: Cefazolin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04875728

NCI-2020-07071 (Registry Identifier)

2020-0265 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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