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

This is an interventional treatment trial for Locally Advanced Soft Tissue Sarcoma focused on measuring Soft tissue sarcoma, Retroperitoneal, Recurrent or locally advanced, CEB-01 PLGA membrane, SN-38, Local drug delivery system Read More

Inclusion Criteria:

1. Age >18 years.
2. 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.
3. 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.
4. Size of tumor (visible or previously inadequately resected) >5 cm at instrumental staging (CT, MRI).
5. 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.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status <2.
7. No concomitant radiotherapy or chemotherapy planned.
8. Life expectancy greater than 6 months.
9. Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
10. Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 3 months after surgery.
11. 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.

Exclusion Criteria:

1. Pregnancy or lactation. Note: Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.
2. Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent.
3. Serious psychiatric disease that precludes informed consent or limits compliance
4. Medical condition limiting survival to less than 6 months.
5. Uncontrolled bacterial, viral or fungal infection.
6. Active viral hepatitis or chronic liver disease.
7. Impossibility of ensuring adequate follow-up.
8. 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.
9. 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.
10. 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.
11. Other relevant concomitant illnesses.
12. Patients previously treated with Irinotecan.