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

NCT04875728 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2020-0265NCI-2020-07071
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in microbiome alpha diversity

  The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.

  Baseline up to 2 weeks post-surgery

Secondary Outcomes (4)

• Change in relative abundance of microbes

  Baseline, at 2 weeks post-surgery, and 3 months post-surgery

• Change in microbiome diversity

  Baseline up to 3 months post-surgery

• Wound (surgical site) infection rate

  Up to 3 months post-surgery

• Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines

  Up to 3 months post-surgery

Study Arms (2)

Arm A (cefazolin, surgical resection)

ACTIVE COMPARATOR

Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.

Drug: Cefazolin; Procedure: Resection

Arm B (surgical resection)

EXPERIMENTAL

Patients undergo standard of care surgical resection.

Procedure: Resection

Interventions

Cefazolin DRUG

Given IV

Arm A (cefazolin, surgical resection)

Resection PROCEDURE

Undergo standard of care surgical resection

Also known as: Surgical Resection

Arm A (cefazolin, surgical resection); Arm B (surgical resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Emily Z Keung

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: May 6, 2021
• Study Start: September 8, 2020
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)