Your session is about to expire
← Back to Search
Anti-tumor antibiotic
L19TNF + Doxorubicin for Metastatic Leiomyosarcoma (FIBROSARC US Trial)
Phase 2
Recruiting
Led By Scott H. Okuno, M.D.
Research Sponsored by Philogen S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histological evidence of stage IV metastatic high-grade leiomyosarcoma (grade 2 - 3 according to the Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system) not amenable to curative treatment with surgery or radiotherapy
ECOG ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1) from week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (maintenance); 3) eot: at week 22/23 (only induction) and at week 72 (maintenance); 4) follow-up: from week 22/23 (eot) up to week 72, every 12 weeks.
Awards & highlights
FIBROSARC US Trial Summary
This trial is testing whether adding a new drug to standard treatment can help people with leiomyosarcoma that has spread to other parts of the body.
Who is the study for?
This trial is for adults and fully grown minors (16+) with stage IV high-grade leiomyosarcoma, a type of soft tissue sarcoma. Participants must have a life expectancy over 3 months, be HIV/HBV/HCV negative, not pregnant or breastfeeding, and willing to use effective contraception. They should not have had previous anthracycline chemo, certain heart conditions or severe diseases that could affect study participation.Check my eligibility
What is being tested?
The study compares the effectiveness of L19TNF in combination with doxorubicin versus doxorubicin alone in treating metastatic leiomyosarcoma. It's an open-label trial where patients are randomly assigned to one of two groups: one receiving the combined treatment and the other just doxorubicin.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts; plus specific risks related to L19TNF like allergic reactions and possibly increased inflammation.
FIBROSARC US Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a high-grade, stage IV leiomyosarcoma that cannot be cured with surgery or radiation.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I am a man who can father children and agree to use two forms of birth control during the study.
Select...
I am a woman who can still have children.
FIBROSARC US Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1) from week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (maintenance); 3) eot: at week 22/23 (only induction) and at week 72 (maintenance); 4) follow-up: from week 22/23 (eot) up to week 72, every 12 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1) from week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (maintenance); 3) eot: at week 22/23 (only induction) and at week 72 (maintenance); 4) follow-up: from week 22/23 (eot) up to week 72, every 12 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Area under the drug concentration-time curve, extrapolated to infinity [AUC].
Duration of response (DOR)
Human anti-fusion protein antibodies (HAFA) levels against L19TNF.
+12 moreFIBROSARC US Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: L19TNF plus doxorubicinExperimental Treatment1 Intervention
Patients will receive a fixed dose of L19TNF in combination with a fixed dose doxorubicin.
Doxorubicin will be administered as a 15 ± 5 minutes i.v. infusion on day 1 of each 21-day cycle followed by at least 30 minutes pause before starting infusion of L19TNF.
Group II: Arm 1: DoxorubicinActive Control1 Intervention
Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion.
Find a Location
Who is running the clinical trial?
Philogen S.p.A.Lead Sponsor
38 Previous Clinical Trials
2,226 Total Patients Enrolled
Scott H. Okuno, M.D.Principal InvestigatorMayo Clinic, Rochester, MN
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My high blood pressure is not controlled, even with treatment.I have not had major surgery or trauma within the last 4 weeks.I have been diagnosed with active or latent tuberculosis.I have been cancer-free from other cancers for at least 2 years, except for soft tissue sarcoma.I have a serious wound or fracture that is not healing.I have tested negative for HIV, hepatitis B, and C.I have had treatment other than surgery or radiation for my inoperable or metastatic soft tissue sarcoma.My cancer is in my limbs and has one distant spread that can be surgically removed.I am allergic to certain cancer drugs or IV proteins.I have severe diabetic eye disease.I regularly take corticosteroids or other drugs that suppress my immune system.I do not have any severe infections or diseases that are not under control.I am currently taking blood thinners.I am not using any cancer treatments other than what this study provides.I have not had a live vaccine in the last 4 weeks and do not plan to get one during the study.I am 16 or older and, if under 18, my growth plates have fused.My cancer is a high-grade, stage IV leiomyosarcoma that cannot be cured with surgery or radiation.I have at least one tumor that can be measured and has not been treated with radiation if it's the only one.I am fully active and can carry on all pre-disease activities without restriction.I am a woman who can still have children.I am a man who can father children and agree to use two forms of birth control during the study.I am eligible for treatment before surgery to shrink my tumor.I am willing and able to follow the study's schedule and procedures.I have severe blockages in my arteries.I am not pregnant and agree to use effective birth control during and 6 months after treatment.I have been treated with anthracycline-based chemotherapy before.I haven't taken growth factors or immune-boosting drugs in the last 7 days.I have not had radiotherapy in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Doxorubicin
- Group 2: Arm 2: L19TNF plus doxorubicin
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.
Are new patients being accepted into the trial currently?
"This clinical trial is actively recruiting patients, according to the listing on clinicaltrials.gov. The study was first posted on December 27, 2018 and was last edited on April 7, 2022."
Answered by AI
Has this research been conducted before?
"Alfacell first sponsored a clinical trial for L19TNF plus doxorubicin in 1997. Since the initial study, which had 300 participants, there have been many more studies done to test this drug's efficacy. In total, 387 active trials are taking place across 67 countries and 1935 cities."
Answered by AI
In how many different medical clinics is this research study being conducted today?
"This study is accepting patients at 10 different locations, including Mayo Clinic in Rochester, Minnesota, Mayo Clinic Hospital in Phoenix, Arizona, and Ohio State University Comprehensive Cancer Center in Columbus, Ohio."
Answered by AI
Has the FDA cleared L19TNF in combination with doxorubicin for patient use?
"L19TNF plus doxorubicin is in Phase 2 of clinical trials, meaning that while there is safety data available, none currently exists to support efficacy. Our team rates it a 2 on our 1-3 scale."
Answered by AI
Can octogenarians participate in this research project?
"Individuals that fall within the age bracket of 16 to 100 years old are able to apply for this clinical trial. Out of the 947 total trials, 252 are for minors and 695 are for adults over the age of 65."
Answered by AI
Who can sign up to participate in this clinical trial?
"The eligibility requirements for this trial state that patients must have leiomyosarcoma and be between 16-100 years old. Right now, the investigators are looking to enroll 114 patients in total."
Answered by AI
What are the primary conditions that L19TNF plus doxorubicin is designed to treat?
"The following cancerous conditions can be improved with L19TNF in conjunction with doxorubicin: lymphoma, hodgkins, carcinoma, bronchogenic, and neuroblastoma (nb)."
Answered by AI
Are there previous cases of L19TNF being used in conjunction with doxorubicin?
"There are currently 387 L19TNF plus doxorubicin clinical trials underway. 121 of these active studies are in Phase 3 testing. Most of the research is conducted in New york, but there are 23777 locations running these sorts of experiments globally."
Answered by AI
Recent research and studies
Popular Categories
Share this study with friends
Copy Link
Messenger