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Antibiotics Before Surgery for Melanoma

Phase 1
Waitlist Available
Led By Emily Z Keung
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult subjects with early stage melanoma (stage I-II)
Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
Must not have
Presence of an infection at the time of surgery
Refusal to participate in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months post-surgery
Awards & highlights
No Placebo-Only Group

Summary

This trialstudies how antibiotics affect the microbes in the stomach/intestines before surgery for melanoma. It may help learn if changes in microbes affect surgery & cancer response.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Cefazolin may cause side effects like allergic reactions, diarrhea, nausea, rash, and possible changes in gut bacteria which could affect digestion and immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have early stage melanoma (stage I or II).
Select...
I am having surgery to remove a tumor and possibly check nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an infection at the time of my surgery.
Select...
I do not want to participate in the study.
Select...
My health is too poor for standard surgical procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in microbiome alpha diversity
Secondary study objectives
Change in microbiome diversity
Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00096226
93%
Fatigue
81%
Dyspnea
72%
Cough
67%
Hemoglobin
65%
Leukopenia NOS
61%
Nausea
60%
Anorexia
60%
Hyperglycemia NOS
58%
Dysphagia
56%
Esophagitis NOS
53%
Dermatitis radiation NOS
49%
Peripheral sensory neuropathy
46%
Weight decreased
44%
Constipation
44%
Alopecia
39%
Neutrophil count
35%
Pneumonitis NOS
33%
Chest pain
32%
Skin hyperpigmentation
30%
Platelet count decreased
30%
Chest wall pain
28%
Hypoalbuminemia
26%
Hyponatremia
25%
Lymphopenia
25%
Diarrhea NOS
25%
Pleural effusion
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Pain - Other
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
18%
Esophageal pain
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Pyrexia
18%
Hypokalemia
18%
Atelectasis
18%
Pneumothorax NOS
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Hypomagnesemia
14%
Back pain
14%
Headache
14%
Dizziness
14%
Pharyngolaryngeal pain
14%
Pruritus
12%
Blood/bone marrow - Other
12%
Pulmonary fibrosis
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Depression
11%
Hypoxia
11%
Laryngitis NOS
11%
Dermatitis exfoliative NOS
11%
Hypotension NOS
9%
Dry mouth
9%
Stomatitis
9%
Blood bilirubin increased
9%
Blood creatinine increased
9%
Anxiety
9%
Thrombosis
9%
Pulmonary/upper respiratory - Other
9%
Dermatology/skin - Other
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Bronchospasm
7%
Hot flushes NOS
7%
Rigors
5%
Gastritis NOS
5%
Vision blurred
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Ataxia
5%
Confusional state
5%
Epistaxis
5%
Rhinitis allergic NOS
5%
Prolonged chest tube drainage or air leak after pulmonary resection
2%
Arrhythmia NOS
2%
Myocardial ischemia
2%
Abdominal distention
2%
Colonic obstruction
2%
Ocular/visual - Other
2%
Ileus paralytic
2%
Serum sickness
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Anal infection NOS
2%
Gingival infection
2%
Urinary retention
2%
Acute respiratory distress syndrome
2%
Erythema multiforme
2%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (surgical resection)Experimental Treatment1 Intervention
Patients undergo standard of care surgical resection.
Group II: Arm A (cefazolin, surgical resection)Active Control2 Interventions
Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2020
Completed Phase 2
~1440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,571 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,560 Total Patients Enrolled
5 Trials studying Cutaneous Melanoma
146 Patients Enrolled for Cutaneous Melanoma
Emily Z KeungPrincipal InvestigatorM.D. Anderson Cancer Center
~7 spots leftby Feb 2027
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