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Immunomodulatory Agent
Leflunomide for Solid Tumors
Phase 1
Recruiting
Led By Deborah Doroshow, MD, PhD
Research Sponsored by Deborah Doroshow
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Advanced or metastatic solid tumor with lack of PTEN expression as determined by immunohistochemistry. Lack of PTEN expression is defined as the absence of staining in the tumor (<5%), with strong positive staining of adjacent normal endometrium or stromal cells, using the monoclonal DAKO antibody 6H2.1.9
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of the drug leflunomide in patients with advanced solid tumors that lack a protein called PTEN.
Who is the study for?
Adults with advanced solid tumors lacking PTEN protein, as confirmed by a specific test. They must have measurable disease, be at least 4 weeks out from prior treatments, and not require immediate brain metastasis treatment. Participants need to be in fair health (ECOG 0-2), have good organ function, and agree to use contraception. Those with HIV can join if their viral load is undetectable.Check my eligibility
What is being tested?
The trial tests Leflunomide's safety and maximum tolerated dose in patients whose tumors don't express the PTEN protein. It also looks for any signs that the drug might help control the cancer.See study design
What are the potential side effects?
Leflunomide may cause liver problems due to its potential hepatotoxicity; it could also lead to allergic reactions similar to those caused by drugs related to it or teriflunomide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer lacks PTEN protein, confirmed by a specific test.
Select...
I can take care of myself and perform daily activities.
Select...
It has been over 4 weeks since my last cancer treatment or surgery.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Dose-limiting toxicities
Number of participants with Dose-limiting toxicities
Secondary outcome measures
Maximum tolerated dose
Overall Response Rate
Side effects data
From 2015 Phase 4 trial • 400 Patients • NCT0117263933%
Upper respiratory tract infection
26%
Abdominal pain
23%
Nausea
19%
Gastroenteritis
16%
Hairloss
14%
Liver function disturbance
12%
Tendinopathy
12%
Arthralgia
9%
Vertigo
9%
Hypertension
9%
Eczema
7%
Increased transpiration
7%
Arthrosis
7%
Back pain
7%
Agitation
7%
Tooth extraction
7%
Paresthesia
7%
Pruritus
5%
Anaemia
5%
Venous insufficiency
5%
Palpitations
5%
Sjogren's disease
5%
Muscle cramps
5%
Influenza infection
5%
Fatigue
5%
Headache
5%
Bronchitis
5%
General malaise
5%
Arthritis
5%
Flushes
2%
Pyrosis
2%
Endometrioid adenocarcinoma
2%
Intervertebral disc disorder
2%
Rotator cuff lesion
2%
Bladder infection
2%
Eye infection
2%
Insomnia
2%
Diarrhoea
2%
Angina
2%
Kidney cancer malignant
2%
Pneumonia
2%
Cough
2%
Genital infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
CoBRA Slim Low Risk Group
Tight Step Up Low Risk Group
CoBRA Classic High Risk Group
CoBRA Slim High Risk Group
CoBRA Avant-garde High Risk Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: LeflunomideExperimental Treatment1 Intervention
Leflunomide, 20-50mg PO daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leflunomide
2003
Completed Phase 4
~1670
Find a Location
Who is running the clinical trial?
Deborah DoroshowLead Sponsor
Deborah Doroshow, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a primary brain tumor.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from most side effects.My cancer did not respond or worsened after standard treatment, or I couldn't tolerate it.I have a history of Hepatitis B or C.My doctor thinks I don't need immediate brain treatment for my cancer.My advanced cancer lacks PTEN protein, confirmed by a specific test.My brain cancer has not worsened after treatment.I can take care of myself and perform daily activities.I have HIV, am on anti-retroviral therapy, and my viral load is undetectable.I have taken a pregnancy test recently and it was negative.It has been over 4 weeks since my last cancer treatment or surgery.My organs and bone marrow are working well.I am 18 years old or older.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Leflunomide
Awards:
This trial has 1 awards, including:- 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.
Does the FDA endorse leflunomide for therapeutic use?
"Our safety score for leflunomide is 1, as it has only been tested at a Phase 1 level with limited evidence of both efficacy and safety."
Answered by AI
Can you elaborate on the previous research conducted regarding Leflunomide?
"Presently, 15 clinical trials using leflunomide are actively being conducted with 2 of them at Phase 3. These studies have expanded to 22 medical sites around the world, including Duarte in California."
Answered by AI
Are there current opportunities to partake in this clinical experiment?
"At the present moment, this research project is not actively seeking participants. According to clinicaltrials.gov, which was updated on July 8th 2022, recruitment for this trial began on August 1st of that same year. If you are interested in alternative studies related to pten-null advanced solid tumors or Leflunomide there are 2380 and 15 trials respectively recruiting patients currently."
Answered by AI
How many participants are actively engaged in this experiment?
"This research project has ceased its patient recruitment process. It was initially posted on August 1st, 2022 and received its last update on July 8th, 2022. Other studies may be of interest; specifically 2380 trials for patients with pten-null advanced solid tumors are presently recruiting participants along with 15 clinical trials involving leflunomide."
Answered by AI
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