5-fluorouracil for Oral Leukoplakia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Oral Leukoplakia+2 More
5-fluorouracil - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

Eligible Conditions

  • Oral Leukoplakia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 3 months

Up to 3 months
Change in area of clinically visible oral leukoplakia lesions
Change in scores on the oral mucosal diseases quality of life questionnaire (COMD-QLQ)
Number of participants with treatment-related adverse events
Proportion of participants with a change in histologic grade
Up to 6 weeks
Proportion of participants s who complete 5-FU injections

Trial Safety

Safety Progress

1 of 3

Side Effects for

Arm B: TAC
97%Alopecia
73%Asthenia
71%Nausea
55%Stomatitis
55%Vomiting
28%Diarrhoea
23%Myalgia
23%Amenorrhoea
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%Weight increased
5%Lacrimation increased
5%Insomnia
5%Affective disorder
5%Cough
3%Lung disorder
3%Peripheral motor neuropathy
3%Back pain
3%Bone pain
2%Lymphoedema
2%Arrhythmia
2%Erythema
2%Haemorrhoids
2%Dyspnoea
2%Urinary tract infection
1%Visual impairment
1%Febrile neutropenia
1%Chest pain
1%Photophobia
1%Hyperhidrosis
1%Flatulence
1%Infection
1%Fatigue
1%Vaginal haemorrhage
1%Metrorrhagia
1%Vaginal infection
0%Breast cyst
0%Dry skin
0%Pigmentation disorder
0%Breast infection
0%Breast haematoma
0%Anaemia
0%Cellulitis
0%Blood bilirubin
0%Carotid artery thrombosis
0%Anal fissure
0%Abdominal pain
0%Device related infection
0%Bronchopneumonia
0%Constipation
0%Deep vein thrombosis
0%Erysipelas
0%Leukopenia
0%Disease progression
0%General physical health deterioration
0%Menorrhagia
0%Postoperative wound infection
0%Ear infection
0%Localised infection
0%Hypersensitivity
0%Tonsillitis
0%Wound infection
0%Thrombosis
0%Pancreatitis
0%Respiratory tract infection
0%Skin infection
0%Thrombocytopenia
0%Anal abscess
0%Varicose vein
0%Herpes zoster
0%Pulmonary embolism
0%Cardiac failure
0%Pleural effusion
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00121992) in the Arm B: TAC ARM group. Side effects include: Alopecia with 97%, Asthenia with 73%, Nausea with 71%, Stomatitis with 55%, Vomiting with 55%.

Trial Design

1 Treatment Group

5-fluorouracil
1 of 1
Experimental Treatment

1 Treatment Group

Primary Treatment: 5-fluorouracil · No Placebo Group · Phase 1

5-fluorouracil
Drug
Experimental Group · 1 Intervention: 5-fluorouracil · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-fluorouracil
2005
Completed Phase 4
~7820

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months
Closest Location: University of California, San Francisco · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
2008First Recorded Clinical Trial
1 TrialsResearching Oral Leukoplakia
687 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,245 Previous Clinical Trials
11,473,626 Total Patients Enrolled
Kyle Jones, DDS, PhDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of any gender, race, or ethnicity.
You have a clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade).
The lesion must be at least 1 cm in diameter.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.