L19TNF plus doxorubicin for Sarcoma
Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
See full descriptionAbout the trial for 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.
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.