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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

Must not have

Uncontrolled hypertension, despite optimal therapy

Known active or latent tuberculosis (TB)

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a high-grade, stage IV leiomyosarcoma that cannot be cured with surgery or radiation.

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I am fully active and can carry on all pre-disease activities without restriction.

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I am a man who can father children and agree to use two forms of birth control during the study.

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I am a woman who can still have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not controlled, even with treatment.

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I have been diagnosed with active or latent tuberculosis.

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I have a serious wound or fracture that is not healing.

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I have had treatment other than surgery or radiation for my inoperable or metastatic soft tissue sarcoma.

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My cancer is in my limbs and has one distant spread that can be surgically removed.

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I am allergic to certain cancer drugs or IV proteins.

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I have severe diabetic eye disease.

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I regularly take corticosteroids or other drugs that suppress my immune system.

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I do not have any severe infections or diseases that are not under control.

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I am currently taking blood thinners.

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I am not using any cancer treatments other than what this study provides.

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I have not had a live vaccine in the last 4 weeks and do not plan to get one during the study.

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I have severe blockages in my arteries.

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I have been treated with anthracycline-based chemotherapy before.

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I have not had radiotherapy in the last 4 weeks.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Area under the drug concentration-time curve, extrapolated to infinity [AUC].

Duration of response (DOR)

Maximum drug concentration [Cmax].

+6 more

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 19Eligibility criteria met