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Clinical Trial 19837

Cancer Type: Sarcoma
Interventions:IL-2 (Interleukin-2); MESNA (); TIL (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • John Mullinax

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients with Soft Tissue Sarcoma

Summary

This is a single-arm trial that will evaluate the feasibility and toxicities of the Tumor-infiltrating lymphocyte (TIL) treatment and the persistence of TIL survival in vivo following treatment.

Objective

The primary objective of this study will be to determine whether patients receiving adoptively transferred, tumor specific T cells after non-myeloablative, lymphodepleting chemotherapy followed by high dose IL-2 have acceptable side effects. Secondary objectives will include degree of sustained persistence of infused T cells and objective anti-tumor responses by RECIST v1.1 evaluations for tumor response

Inclusion Criteria

  • Participants must fulfill all of the following criteria to be eligible for the study at the time of tumor resection and initiation of TIL expansion.
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Participants must have metastatic, high-grade soft tissue sarcoma, all subtypes will be eligible
  • Residual measurable disease after resection of target lesion(s) for TIL growth
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1. ECOG performance status of 0 to 1 will be inferred if the patient¿s level of energy is ≥ 50% of baseline.
  • Participants must have progressed on at least one prior standard of care treatment regimen for metastatic disease.
  • A negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential.
  • A MUGA scan (ejection fraction > 50% is required) ≤ 6 months prior to lymphodepletion.
  • Pulmonary function tests (forced expiratory volume (FVC) 1 > 65% or FVC > 65% of predicted are required) are required ≤ 6 months prior to lymphodepletion for those who are smokers of > 10 packs per year of cigarettes or have any history of pulmonary disease.
  • Adequate renal, hepatic, and hematologic function, including creatinine of ≤ 1.7 gm/dL, total bilirubin ≤ 2.0 mg/dL, except in patients with Gilbert¿s Syndrome who must have a total bilirubin less than 3.0 mg/dL, AST and ALT of less than 3 X institutional upper limit of normal, hemoglobin of 8 gm/dL or more, white blood cells of 3000 per mm^3 and total granulocytes of 1000 per mm^3 or more, and platelets of 100 000 per mm^3 or more.
  • Participants must have a positive screening EBV antibody titre on screening test.
  • Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the participant agrees to continue to use a method of contraception throughout the study such as: barrier (i.e. condom, diaphragm), hormonal, IUD, or sponge plus spermicide.
  • Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normal
  • Participants with echocardiogram (EKG) within 14 days of initiation of chemotherapy demonstrating no new rhythm, axis, or ST segment
  • Urinalysis within 14 days demonstrating no evidence of a urinary tract infection.

  • Exclusion Criteria

  • Participants with active systemic infections requiring intravenous antibiotics, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system are excluded.
  • Participants testing positive for HIV titer, hepatitis B surface antigen, hepatitis C antibody, human T-cell leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and fluorescent treponemal antibody(FTA) are excluded.
  • Participants who are pregnant or nursing are excluded.
  • Participants needing chronic immunosuppressive systemic steroids are excluded
  • Participants with autoimmune diseases that require immunosuppressive medications are excluded
  • Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated
  • Participants with central nervous system metastases will be excluded. Inability to comprehend and give informed consent