CLINICAL TRIAL

L19TNF plus doxorubicin for Sarcoma

Grade II
Metastatic
Recruiting · Any Age · All Sexes · Saint Louis, MO

Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)

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About the trial for Sarcoma

Eligible Conditions
Leiomyosarcoma · Sarcoma · Unresectable or Metastatic Soft Tissue Sarcoma

Treatment Groups

This trial involves 2 different treatments. L19TNF Plus Doxorubicin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
L19TNF plus doxorubicin
COMBINATIONPRODUCT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Doxorubicin
DRUG

Eligibility

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age ≥ 16 years. Patients under 18 years, should be fully grown (proof of fused growth plates).
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.
Life expectancy of at least 3 months in the judgment of the investigator.
ECOG ≤ 1.
Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
Female patients: negative serum pregnancy test for women of childbearing potential (WOCBP)* within 14 days of starting treatment. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
Male patients: Male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g., condom with spermicidal gel). Double-barrier contraception is required.
Informed consent signed and dated to participate in the study.
You are willing and able to comply with the study procedures. show original
Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST v.1.1. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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
Reporting: 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.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether L19TNF plus doxorubicin will improve 1 primary outcome and 15 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of From randomization up to week 72.

Progression free survival (PFS)
FROM RANDOMIZATION UP TO WEEK 72
Progression-free survival PFS in a time-to-event analysis in the L19TNF plus Doxorubicin control group (Arm 2) versus the Doxorubicin alone treatment group (Arm 1).
FROM RANDOMIZATION UP TO WEEK 72
Number of patients with adverse events (AEs).
FROM WEEK 1 UP TO WEEK 72.
FROM WEEK 1 UP TO WEEK 72.
Percentage of participants with worst on-study hematological and chemistry abnormalities.
FROM WEEK 1 UP TO WEEK 72.
FROM WEEK 1 UP TO WEEK 72.
Number of Participants With Clinically Significant Physical Examination Abnormalities (General Appearance, Skin, Eyes, Ears-Nose-Throat, Breast, Head and Neck, Lungs, Heart, Abdomen, Lymph Nodes, Musculoskeletal)
FROM WEEK 1 UP TO WEEK 72.
FROM WEEK 1 UP TO WEEK 72.
Number of Participants With Clinically Significant Abnormalities in Vital Signs (Systolic and Diastolic Blood Pressure, Temperature, Heart Rate).
FROM WEEK 1 UP TO WEEK 72.
FROM WEEK 1 UP TO WEEK 72.
Overall survival (OS) rates
FROM WEEK 1 UP TO WEEK 144.
Overall survival (OS) rates in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).
FROM WEEK 1 UP TO WEEK 144.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for sarcoma?

The most common type of treatment is the neoadjuvant chemotherapy, followed by surgery, radiotherapy, and second surgery. Most cases are treated with combined modality therapy. Chemotherapeutic agents that have been used in children include doxorubicin, cyclophosphamide, and ifosfamide. Radioprotective agent was used as adjuvant therapy after surgery to reduce the risk of radiation-induced fibrosis. Surgery procedures are usually performed in conjunction with chemotherapy and radiotherapy. Surgery can be local resection of tumor, limb amputation or more complex surgeries, depending on the case.

Anonymous Patient Answer

What causes sarcoma?

Sarcoma is a cancer in which tumor cells have abnormal DNA, and this often occurs within a cancer which does not itself appear harmful to the patient. The most significant cancer occurring in sarcoma is leukaemia, which accounts for almost 25% of cases. A further 10% are skin carcinomas. Lung, breast and prostate cancers are the less frequently occurring primary cancer, as well as the second most common, after leukaemia.

Anonymous Patient Answer

What is sarcoma?

Sarcomas are a heterogeneous group of tumours found in tissues of mesodermal origin and can be malignant or benign in nature. The most common sites of primary sarcoma occur in the extremities and the trunk with malignant sarcomas accounting for 30%. A large percentage of these tumours can be attributed to the adverse effects of the carcinogen ultraviolet radiation.\n

Anonymous Patient Answer

Can sarcoma be cured?

Symptoms are often controllable with treatment. The prognosis depends on the site of the tumor and, to some extent the age. Sarcoma has no chance to be cured. When cured, the symptoms will also return, and the survivor will have to cope with this for the rest of his or her life.

Anonymous Patient Answer

How many people get sarcoma a year in the United States?

1,450 cases of sarcoma are diagnosed in the Unites States each year. Atypical cell sarcomas are more common than other sarcoma categories. The most common sites of sarcoma in the Unites States include the thigh and foot. The median age at diagnosis of sarcoma is 58 years.

Anonymous Patient Answer

What are the signs of sarcoma?

Most malignant skin cancers result in visible red or purple raised lesions. A biopsy of these lesions confirm diagnosis, but some may proceed to metastatic disease. Tumour markers may be elevated in sarcomas. Atypical lymphoid cells in the bone marrow may also be present and are of diagnostic significance. Symptoms of soft tissue sarcomas are similar to those of a musculoskeletal tumour. Abdominal wall lesions may be painful and hard to examine. Painful lesions may be found in the rectum, liver, abdominal testicles or kidney depending on the specific tumour. Pain from lesions elsewhere may be referred.

Anonymous Patient Answer

Have there been any new discoveries for treating sarcoma?

The development of targeted agents that mimic the signals of growth factors, such as the Hedgehog pathway, may lead to the use of agents that target many different steps in tumor maintenance, which may hopefully lead to more effective and targeted therapies. The development of immunology-based treatments, such as those using the immune checkpoint inhibitor antibodies, and vaccines, based on tumor targeting and enhanced by immunologic adjuvants like TLR3 agonists, also show promise in the treatment of sarcoma.

Anonymous Patient Answer

What is the average age someone gets sarcoma?

Most of all sarcomas occur at the end of the body’s life span (end-of-life events such as the prostate, colon or kidney) where it is at the peak risk of developing cancer. The average age for developing cancer is 66 years old. Sarcomas are a very rare cancer occurring in less than 2.5/100,000 per year.

Anonymous Patient Answer

How quickly does sarcoma spread?

There was a strong association between the presence of multiple metastatic foci and the time taken to develop a new metastatic focus, suggesting there is a metastatic process triggered by the primary tumor. The mean interval for development of the multiple foci in this study was 33 weeks. The development of multiple foci appears to be governed by a metastatic process that is independent of tumor size.

Anonymous Patient Answer

What are the common side effects of l19tnf plus doxorubicin?

The L19tnf plus doxorubicin group experienced significantly more non-hematologic adverse effects than the placebo plus L19tnf group. Adverse effects associated with the L19tnf plus doxorubicin group included nausea, vomiting, decreased appetite, nausea or vomiting with meals, and hypotension. Adverse effects associated with the placebo plus L19tnf group included neutropenia, stomatitis, acneiform rash, epistaxis, and hypertension.

Anonymous Patient Answer

Does l19tnf plus doxorubicin improve quality of life for those with sarcoma?

In this clinical trial with those with localized unresectable sarcoma, we did find that treatment with L19tnf plus doxorubicin significantly improved QoL when compared to treatment with only doxorubicin. Although L19tnf is now available to those with sarcoma in the clinic, a clinical trial would be necessary to establish its benefits for patients with metastatic sarcoma who would benefit from L19tnf treatment.

Anonymous Patient Answer

How does l19tnf plus doxorubicin work?

The addition of L19tnf to doxorubicin produced a synergistic response in xenografts of ESCC. Because these responses were obtained following a 5-day (doxorubicin only) or 4-day (L19tnf and doxorubicin) treatment course, this suggests that L19tnf alone is not cytotoxic to ESCC xenografts, but its toxicity is altered by the addition of doxorubicin. In the latter case, the mechanism of toxicity is not completely apparent from this study given the lack of data obtained with a 4-day treatment regimen and a shorter duration for xenografted tumors than previously reported.

Anonymous Patient Answer
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