What side effects are associated with this type of intervention?

Common treatments for Soft Tissue Sarcoma, such as Doxorubicin and TNF-targeting therapies like L19TNF, have several known side effects. Doxorubicin is associated with cardiotoxicity, myelosuppression, nausea, vomiting, and alopecia. TNF-targeting therapies can cause flu-like symptoms, hypotension, and increased risk of infections due to immune modulation. Both treatments can lead to significant fatigue and impact overall quality of life. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks of these therapies.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Soft Tissue Sarcoma (STS). Doxorubicin, an anthracycline antibiotic, is a cornerstone in STS treatment due to its ability to intercalate DNA and inhibit cancer cell replication. Additionally, Pazopanib, a tyrosine kinase inhibitor, has been approved for advanced STS, providing a targeted approach by inhibiting angiogenesis. While immune checkpoint inhibitors like Pembrolizumab have shown promise in enhancing immune response in various cancers, their specific approval for STS is still under investigation. These treatments reflect a combination of traditional chemotherapy and targeted therapies aimed at improving patient outcomes in STS.

What other types of research exist?

Promising novel alternatives for Soft Tissue Sarcoma patients include multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib. These inhibitors target VEGFR and other kinases and have shown some activity in advanced osteosarcoma. Additionally, immune checkpoint inhibitors like anti-PD-1 or anti-PD-L1 therapies, potentially combined with anti-CTLA-4, are emerging options based on their efficacy in other cancers. Clinical trials investigating these agents are also appropriate for consideration.

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Anti-tumor antibiotic

L19TNF + Doxorubicin for Soft Tissue Sarcoma (DOXO75 Trial)

Phase 1

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, 12 and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests L19TNF with doxorubicin in patients with severe soft tissue sarcoma. It aims to see if this combination is safe and effective. L19TNF helps target cancer cells more precisely, while doxorubicin kills the cancer cells. Selinexor is a new type of treatment that has shown promise in treating soft tissue sarcoma.

Who is the study for?

Adults aged 18-85 with advanced soft tissue sarcoma, excluding Kaposi's sarcoma and GIST, who haven't had certain prior treatments or have uncontrolled diseases. They must not be pregnant, agree to use effective contraception, have a measurable lesion by CT scan per RECIST criteria, an ECOG ≤ 2, and a life expectancy of at least 3 months.

What is being tested?

The trial is testing the safety of combining L19TNF with doxorubicin in patients with soft tissue sarcoma. The goal is to find the best dose of doxorubicin that can be safely used alongside L19TNF.

What are the potential side effects?

Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, increased risk of infection due to low blood cell counts; specific risks related to L19TNF are not detailed but could involve reactions similar to other immune-targeting therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, 12 and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9, 12 and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12 and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure

Calculation of the body surface area (BSA)

Echocardiogram (ECHO) findings

+6 more

Secondary study objectives

Efficacy of L19TNF in combination with doxorubicin: Disease Control Rate

Efficacy of L19TNF in combination with doxorubicin: Overall response rate

HAFA measurement

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm L19TNF + DOXOExperimental Treatment2 Interventions

Patients will be treated with: * doxorubicin 75 mg/m2 i.v. on day 1 of each 21-day cycle; * L19TNF 13 µg/kg i.v. on day 1, 3 and 5 of each 21-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L19TNF

2019

Completed Phase 2

~20

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Soft Tissue Sarcoma (STS) include therapies like L19TNF and Doxorubicin. L19TNF works by targeting tumor necrosis factor (TNF) to the tumor environment, which enhances the immune system's ability to attack cancer cells. Doxorubicin intercalates into DNA, inhibiting the replication of cancer cells and leading to their death. These mechanisms are significant for STS patients as they combine immune system activation with direct cancer cell inhibition, potentially improving treatment efficacy and patient outcomes.

Immune infiltrates in patients with localised high-risk soft tissue sarcoma treated with neoadjuvant chemotherapy without or with regional hyperthermia: A translational research program of the EORTC 62961-ESHO 95 randomised clinical trial.Turning 'Cold' tumors 'Hot': immunotherapies in sarcoma.Response to radiotherapy in pancreatic ductal adenocarcinoma is enhanced by inhibition of myeloid-derived suppressor cells using STAT3 anti-sense oligonucleotide.