First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma

Prior treatment

• Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent.
• Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumor biopsy nor central line insertion are considered a major surgery.
• Unable or unwilling to stop the use of herbal supplements; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation.
• Other relevant concomitant illnesses.
• Patients previously treated with Irinotecan.

Other illness

• Serious psychiatric disease that precludes informed consent or limits compliance
• Medical condition limiting survival to less than 6 months.
• Uncontrolled bacterial, viral or fungal infection.
• Active viral hepatitis or chronic liver disease.

Other

• Pregnancy or lactation. Note: Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.
• Impossibility of ensuring adequate follow-up.
• Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or an aneurysm clip, severe claustrophobia, a known reaction to the gadolinium contrast dye, or body weight that could interfere with the feasibility of a MRI.

• Age \>18 years.
• Histologically confirmed diagnosis of locally advanced (T3 -T4, American Joint Committee on Cancer (AJCC)/primary tumor, regional lymph nodes, and distant metastases staging system (TMN) 8th Edition) and/or relapsed (any) retroperitoneal soft tissue sarcoma (liposarcoma, leiomyosarcoma, a solitary fibrous tumor (SFT), pleomorphic sarcoma, or a malignant nerve sheath tumor). Patients with local advanced (T3 -T4,AJCC/TMN 8th Edition) and/or relapse and metastatic disease who are candidates for local surgery without option of systemic treatment, are also eligible for the trial.
• Pathology specimens available for centralized review. Submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central reviewing is required; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted.
• Size of tumor (visible or previously inadequately resected) \>5 cm at instrumental staging (CT, MRI).
• Normal liver, renal, hematological, and cardiac function as defined by biochemical and hematological parameters as follows: Hb \>11 g/dL, platelets \>100.000/mm3, White Blood Cells (WBC) \>3000/mm3, neutrophil count \>1500/mm3, albumin \>3.0 g/dl, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \<2.5 times the upper limit of normality (ULN), bilirubin \<2 times the ULN, creatinine \<1.5 mg/dl or creatinine clearance \> 60 ml/min.
• Eastern Cooperative Oncology Group (ECOG) Performance Status \<2.
• No concomitant radiotherapy or chemotherapy planned.
• Life expectancy greater than 6 months.
• Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
• Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 3 months after surgery.
• Ability to understand and the willingness to sign a written informed consent document; subject has signed an Informed Consent Form (ICF) prior to any screening procedures and is able to comply with protocol requirements.