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Anti-metabolites

5-Fluorouracil + Imiquimod for Skin Cancer

Phase 1

Recruiting

Led By Melissa Pugliano-Mauro, MD

Research Sponsored by Melissa Pugliano-Mauro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-confirmed SCC more than 1.0 cm and less than 2.0 cm in diameter in the lower extremities, defined as the knees and below

Patient is ≥ 18 years of age on day of signing informed consent

Must not have

Patients with evidence of active infection - active and/or untreated hepatitis B/C, HIV, etc - requiring systemic therapy

Patients with the following cardiac co-morbidities including: Baseline known prolongation of QT/QTc interval (QTc interval >500 msec), Heart failure either on clinical examination or based on known decreased left ventricular ejection fraction (LV EF) <50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new way to treat skin cancer by directly injecting a chemotherapy drug into the tumor. The goal is to see if it's safe and effective.

Who is the study for?

This trial is for adults with biopsy-confirmed squamous cell carcinoma (SCC) on the lower legs, who are expected to live more than a year and have good performance status. They must not be on other investigational treatments or have had cancer therapy within four weeks. Women of childbearing potential must test negative for pregnancy and use contraception.

What is being tested?

The study tests injecting a chemotherapy drug called 5-fluorouracil (5FU) directly into SCC tumors in the lower extremities, with or without an additional topical cream called imiquimod. The aim is to assess safety, tolerability, and how well the tumor responds three weeks post-treatment.

What are the potential side effects?

Potential side effects include reactions at the injection site like pain or inflammation, skin irritation from imiquimod cream, fatigue, nausea, and increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a skin cancer spot between 1.0 and 2.0 cm on my leg below the knee.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active infections needing treatment.

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I have heart issues, including long QT syndrome or heart failure.

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I do not have serious illnesses like heart disease, bleeding disorders, severe lung conditions, active infections, or inflammatory bowel diseases.

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My cancer is a type of SCC that did not start in the skin.

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I have had an organ transplant.

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My cancer has spread to lymph nodes or other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine number of subjects experiencing Dose Limiting Toxicity (DLT) higher than grade 2, as defined by CTCAE v. 4.0

Secondary study objectives

Asses clinical objective response rate

Side effects data

From 2013 Phase 3 trial • 1060 Patients • NCT00121992

97%

Alopecia

73%

Asthenia

71%

Nausea

55%

Stomatitis

55%

Vomiting

28%

Diarrhoea

23%

Amenorrhoea

23%

Myalgia

22%

Pain

20%

Arthralgia

20%

Conjunctivitis

19%

Nail disorder

19%

Menstruation irregular

19%

Oedema peripheral

18%

Skin disorder

17%

Abdominal pain upper

17%

Pyrexia

17%

Decreased appetite

16%

Dysgeusia

16%

Peripheral Sensory Neuropathy

14%

Hot flush

13%

Fever in absence of infection

11%

Dyspepsia

Neutropenia

Lacrimation increased

Cough

Weight increased

Insomnia

Affective disorder

Lung disorder

Peripheral motor neuropathy

Back pain

Bone pain

Lymphoedema

Erythema

Arrhythmia

Haemorrhoids

Dyspnoea

Urinary tract infection

Hyperhidrosis

Flatulence

Febrile neutropenia

Metrorrhagia

Fatigue

Visual impairment

Chest pain

Photophobia

Infection

Vaginal haemorrhage

Vaginal infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm B: TAC

Arm A: FAC

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: 5FU GroupExperimental Treatment1 Intervention

5-fluorouracil (5FU) Group participants will receive a 1ml intralesional injection of 5FU 50mg/ml aqueous injectable solution. One injection will be administered weekly for 3 weeks. Injections will occur on d0, d7, and d14. Standard of care will be administered on d21 of study and lesion will be surgical resected.

Group II: 5FU + Imiquimod 5% GroupExperimental Treatment2 Interventions

5-fluorouracil (5FU) + Imiquimod 5% cream Group participants will receive intralesional 5FU as in the previous group, additionally participants will also receive three-times-weekly topical application of 5% imiquimod to the same lesion. Standard of care will be administered on d21 of study and lesion will be surgical resected.

Group III: Control GroupActive Control1 Intervention

Control group will receive neither 5-fluorouracil (5FU) injection nor topical Imiquimod 5% cream. This group will receive standard of care only. Lesion will be surgical resected on day 21 of study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imiquimod

FDA approved

Fluorouracil

FDA approved

0 / 9Eligibility criteria met