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

Status unconfirmed · Phase 2

Conditions studied: Leiomyosarcoma

In brief

The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.

Key facts

Study ID

NCT03420014

Run by

Philogen S.p.A.

People needed

114

Starts

2018-12-27

Expected to finish

2025-12-01

Last updated by the study team

2023-10-10

Who can join

Age: 16 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be included in the study if they meet all of the following criteria:
• 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.
• Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1. If only 1 lesion is present at screening this lesion should not have been irradiated during previous treatments.
• 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.
• Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
• Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).

You may not qualify if…

• Patients will be excluded from participating in this study if they meet one or more of the following criteria:
• Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma (STS).
• Patients with primary tumor localized to the extremities and a single resectable synchronous distant metastatic lesion.
• Patients eligible for neoadjuvant preoperative treatment.
• Previous treatment with anthracycline-containing chemotherapy.
• Radiotherapy within 4 weeks prior to start of therapy.
• Known history of allergy to TNFα, anthracyclines or other intravenously (IV) administered human proteins/peptides/antibodies.
• Absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L and haemoglobin (Hb) < 9.0 g/dl.
• Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN.
• Inadequate liver function (ALT, AST, GGT, ALP or total bilirubin ≥ 1.5 x ULN) or total bilirubin ≥ 1.5 x ULN).
• International normalized ratio (INR) > 1.5 ULN.
• Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
• History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• Heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
• Left Ventricular Ejection Fraction (LVEF) < 50%.
• Clinically significant cardiac arrhythmias or requiring permanent medication.
• Abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT/QTc prolongation would be excluded. In particular:
• patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc >480 milliseconds using Fredricia's QT correction formula) are excluded;
• patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded;
• patients who require the use of concomitant medications that prolong the QT/QTc interval are excluded.
• Uncontrolled hypertension, despite optimal therapy.
• Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
• Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
• Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
• Pregnancy or breast-feeding.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
• Sarcoma Oncology Research Center (SORC) Cancer Center of Southern California — Santa Monica, California, United States (enrolling)
• Mayo Clinic Hospital — Jacksonville, Florida, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Rutgers Cancer Institute of New Jersey 195 Little Albany Street New Brunswick, NJ 08901 Room 2031 — New Brunswick, New Jersey, United States (enrolling)
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Seattle Cancer Care Alliance 825 Eastlake Ave. E. Seattle, WA 98109 Mail Stop CE2-128 — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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