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

• Status: Recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cefazolin

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