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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a skin cancer spot between 1.0 and 2.0 cm on my leg below the knee.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine number of subjects experiencing Dose Limiting Toxicity (DLT) higher than grade 2, as defined by CTCAE v. 4.0
Secondary outcome measures
Asses clinical objective response rate
Side effects data
From 2013 Phase 3 trial • 1060 Patients • NCT0012199297%
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
6%
Neutropenia
5%
Cough
5%
Lacrimation increased
5%
Weight increased
5%
Insomnia
5%
Affective disorder
3%
Lung disorder
3%
Peripheral motor neuropathy
3%
Back pain
3%
Bone pain
2%
Lymphoedema
2%
Erythema
2%
Arrhythmia
2%
Haemorrhoids
2%
Dyspnoea
2%
Urinary tract infection
1%
Flatulence
1%
Metrorrhagia
1%
Hyperhidrosis
1%
Febrile neutropenia
1%
Fatigue
1%
Visual impairment
1%
Chest pain
1%
Photophobia
1%
Infection
1%
Vaginal haemorrhage
1%
Vaginal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: TAC
Arm A: FAC
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
Fluorouracil
FDA approved
Imiquimod
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Melissa Pugliano-MauroLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
Melissa Pugliano-Mauro, MD5.01 ReviewsPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.I have fully recovered from any major surgery before starting treatment.I use topical steroids or creams for a skin condition as advised by my doctor.I had cancer before, but I've been free of it for 5 years after treatment.I have a skin cancer spot between 1.0 and 2.0 cm on my leg below the knee.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use effective birth control or abstain from sex during the study and for 120 days after.I do not have any active infections needing treatment.I have heart issues, including long QT syndrome or heart failure.I do not have serious illnesses like heart disease, bleeding disorders, severe lung conditions, active infections, or inflammatory bowel diseases.My cancer is a type of SCC that did not start in the skin.I will not need any cancer treatment other than the study's while participating.I have had an organ transplant.My cancer has spread to lymph nodes or other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: 5FU Group
- Group 3: 5FU + Imiquimod 5% Group
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What ailments does 5-fluorouracil tend to address?
"5-fluorouracil has been effectively used to treat basal cell carcinoma, rectal carcinoma, communicable maladies, and scalp structure."
Answered by AI
Has the Federal Drug Administration accepted 5-fluorouracil for use?
"Our Power team rated 5-fluorouracil with a score of 1 as this is currently in its first phase trial, which implies limited evidence for both safety and efficacy."
Answered by AI
Are there currently any open slots for enrolment in this experiment?
"According to the clinicaltrials.gov entry, this medical trial is still open and actively recruiting participants. It was first published on August 3rd 2018 before being updated most recently on October 6th 2022."
Answered by AI
What other experimental treatments have included 5-fluorouracil in their research?
"Currently, 333 studies are actively exploring the use of 5-fluorouracil and 105 trials have reached Phase 3. Houston, Texas is the main center for these investigations however there are 17886 locations across America testing this medication."
Answered by AI
How many test subjects are being administered this research protocol?
"Yes, the details on clinicaltrials.gov indicate that this medical research is currently recruiting participants. The trial was posted for the first time on August 3rd 2018 and subsequently updated October 6th 2022; it requires 30 individuals across a solitary site."
Answered by AI
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