Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT04052334|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: TIL Drug: Interleukin-2 Drug: Fludarabine Drug: Cyclophosphamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Lymphodepletion Plus Adoptive Cell Therapy With High-Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma|
|Actual Study Start Date :||August 8, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: Infusion of Tumor-infiltrating lymphocyte
Participants will undergo tumor resection from which the tumor infiltrating lymphocyte (TIL) product will be generated. All participants will receive nonmyeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T-cell persistence and effectiveness in vivo. Cyclophosphamide will be administered at 60 mg/kg/day IV in 250 mL normal saline (NS). Fludarabine will then be infused at 25 mg/m^2 intravenous piggyback (IVPB). All participants will receive not less than 10^9, and up to 1x10^12 T cells in ≥250 mL NS as an inpatient by intravenously (IV).
Eight (8) to sixteen (16) hours after completing the T cell infusion, all participants will receive high-dose interleukin-2 (IL-2) on an inpatient basis at the standard dose of 600 000 IU/kg as an intravenous bolus over an approximate 15-minute period every 8 to 16 hours for up to 15 doses on days 1 to 5, as tolerated.
Participants will receive an infusion of Tumor-infiltrating lymphocytes (TIL) after tumor resection and TIL product is generated.
Other Name: Tumor-infiltrating lymphocytes
Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously (IV) bolus (about 15 minutes) every 8 to 16 hours for up to 15 doses, beginning approximately 12 to 16 hours after T-cell infusion.
Other Name: IL-2
Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 30 minutes for 5 days, prior to T-Cell infusion
Other Name: Fludara
Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL normal saline (NS) over approximately 2 hours, 7 days prior to T-Cell infusion
- Number of participants who experienced Serious Adverse Events and Adverse Events [ Time Frame: Baseline to 12 months ]Participants able to safely tolerate preparatory lymphodepletion, infusion of tumor-infiltrating lymphocytes (TIL) and subsequent IL-2, as measured by adverse events and serious adverse events.
- Number of participants with objective antitumor response [ Time Frame: At 12 weeks ]Number of participants with objective response (Complete Response (CR) + Progressive Response (PR)) rate at 12 weeks following TIL infusion, as measured by RECIST v1.1
- Number of participants with circulating tumor-infiltrating lymphocytes (TIL) product at 6 weeks [ Time Frame: At 6 weeks ]Number of participants with persistence of TIL infusion product at 6 weeks following treatment, as measured by T-cell receptor repertoire comparison between the infusion product and circulating Peripheral blood mononuclear cell (PBMC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052334
|Contact: Brook Olmo||813-745-5221||Brook.Olmo@moffitt.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Brook Olmo 813-745-5221 Brook.Olmo@moffitt.org|
|Sub-Investigator: Andrew Brohl, MD|
|Sub-Investigator: Mihaela Druta, MD|
|Sub-Investigator: Ricardo Gonzalez, MD|
|Sub-Investigator: Shari Pilon-Thomas, PhD|
|Sub-Investigator: Damon Reed, MD|
|Sub-Investigator: Amod Sarnaik, MD|
|Principal Investigator:||John Mullinax, MD||Moffitt Cancer Center|