Antibiotics Before Surgery for Melanoma

Overseen By Emily Z. Keung

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Corticosteroids, Immunosuppressives

Disqualifiers: Infection, Pregnancy, ASA grade > IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have used antibiotics in the three months before surgery or be on certain immune system medications within 14 days of the study drug.

What data supports the effectiveness of the treatment Cefazolin, Resection, Surgical Resection, Surgical Excision for melanoma?

Research suggests that timely surgical excision is crucial for improving survival rates in melanoma patients, with those undergoing surgery within 6 weeks of diagnosis having better outcomes. Additionally, perioperative antibiotics like Cefazolin may help reduce the risk of infections after surgery, which can be beneficial in the overall treatment process. ^{1 2 3 4 5}

Is it safe to use antibiotics before surgery for melanoma?

Using antibiotics before surgery is generally considered safe, but their use is often debated and typically prescribed only if there's a clear need. Dermatological surgeries, including those for melanoma, are usually safe, but there is a risk of infections, which antibiotics can help prevent. ^{1 6 7 8 9}

How does the treatment of surgical resection for melanoma differ from other treatments?

Surgical resection for melanoma involves removing the tumor with specific margins based on its depth and location, aiming for local control and long-term survival without significant functional or aesthetic impairment. This approach is unique because it focuses on achieving the most conservative yet effective surgical margins to ensure the same results as more extensive surgeries. ^{6 7 10 11 12}

Research Team

Emily Z. Keung

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with early stage melanoma (stage I-II) who are scheduled for surgery to remove the cancer. Participants must not have used antibiotics in the last three months, be pregnant, or allergic to beta-lactam/cephalosporin antibiotics. They should not have infections or conditions that increase infection risk.

Inclusion Criteria

I have early stage melanoma (stage I or II).

I can sign and follow the study's consent form.

I am having surgery to remove a tumor and possibly check nearby lymph nodes.

Exclusion Criteria

I have not taken antibiotics in the three months before surgery.

I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

I have an infection at the time of my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive cefazolin intravenously and undergo standard of care surgical resection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in microbiome and immune response post-surgery

3 months

3 visits (in-person) at 3 days, 2 weeks, and 3 months

Treatment Details

Interventions

• Cefazolin
• Resection

Trial Overview The study is testing how taking the antibiotic cefazolin before surgery affects the microbiome of patients with stage I-II melanoma. Researchers want to see if changes in gut microbes influence recovery and response to cancer treatment.

Participant Groups

Group I: Arm B (surgical resection) Experimental Treatment 1 Intervention

Patients undergo standard of care surgical resection.

Group II: Arm A (cefazolin, surgical resection) Active Control 2 Interventions

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

Resection is already approved in United States, European Union for the following indications:

Approved in United States as Surgical Resection for:

• Colorectal Cancer
• Liver Metastases
• Lung Metastases

Approved in European Union as Surgical Excision for:

• Colorectal Cancer
• Liver Metastases
• Lung Metastases

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 6,496 melanoma patients diagnosed between 2004 and 2012, those who underwent surgical excision within 6 weeks of diagnosis had a significantly higher 5-year overall survival rate (86%) compared to those who waited more than 90 days (78.6%).

The results suggest that timely surgical intervention is crucial for improving survival outcomes, particularly for patients with Stage 1 melanoma, highlighting the importance of prompt treatment after diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of surgical interval and survival among hospital and non-hospital based patients with melanoma in North Carolina. Adamson, AS., Jackson, BE., Baggett, CD., et al.[2022]

A retrospective study of New Zealand dermatologists revealed that while dermatological surgeries in outpatient settings are generally safe, with low rates of infection (<3.5%) and bleeding (<2%), there is a need for improved preoperative and intraoperative monitoring practices.

Most dermatologists do not routinely record vital signs during procedures and often do not withhold anticoagulation or antiplatelet therapies, indicating a potential gap in safety protocols that could be addressed to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative management and the associated rate of adverse events in dermatological procedures performed by dermatologists in New Zealand. Chan, BC., Patel, DC.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Do perioperative antibiotics reduce the risk of surgical-site infections following excision of ulcerated skin cancers? A Critically Appraised Topic. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Association of surgical interval and survival among hospital and non-hospital based patients with melanoma in North Carolina. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The surgical approach to primary malignant melanoma. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Melanoma recurrence after excision. Is a wide margin justified? [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term outcomes and prognostic factors of high-risk malignant melanoma patients after surgery and adjuvant high-dose interferon treatment: a single-center experience. [2015]

6. Mexico pubmed.ncbi.nlm.nih.gov

Incidence of complications in dermatological surgery of melanoma and non-melanoma skin cancer in patients with multiple comorbidity and/or antiplatelet-anticoagulants. Five year experience in our Hospital. [2023]

7. Mexico pubmed.ncbi.nlm.nih.gov

Incidence of complications in dermatological surgery of melanoma and non-melanoma skin cancer in patients with multiple comorbidity and/or antiplatelet-anticoagulants. Five year experience in our Hospital. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Characteristics of Gram-Negative Surgical Site Infections in Patients Treated With Mohs Micrographic Surgery: A Retrospective Analysis. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Perioperative management and the associated rate of adverse events in dermatological procedures performed by dermatologists in New Zealand. [2015]

10. Poland pubmed.ncbi.nlm.nih.gov

Re-excision within a radius of 2 cm in patients with melanoma of the skin - sufficient for local oncological radicalness. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of the primary in malignant melanoma of the skin. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Surgery of primary melanomas. [2021]