Study of Lymphodepletion Plus Adoptive Cell Transfer With T-Cells Transduced With CXCR2 and Nerve Growth Factor Receptor (NGFR) Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma
Drug: Fludarabine monophosphate
Procedure: T cell Infusion
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Lymphodepletion Plus Adoptive Cell Transfer With T-Cells Transduced With CXCR2 and Nerve Growth Factor Receptor (NGFR) Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma|
- Toxicity of CXCR2 Transduced Tumor Infiltrating Lymphocytes (TIL) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Phase 1 Toxicity, defined as a grade 3 or 4 non-hematologic toxicity that cannot be resolved therapeutically within 2 weeks of onset, including nausea/vomiting, transaminitis, neutropenia with fever, and thrombocytopenia using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 4.0 . Toxicities monitored daily basis beginning Day 0 (T-cell infusion) and continuing until discharged from hospital following the initial IL-2 infusion.
Toxicity reporting: a.) Grade 2 or greater allergic reaction and b.) Grade 3 or 4 non-heme toxicities with the exception of: IL-2 expected toxicities; and Toxicities occurring within 24 hours post cell infusion that are reversible to grade 2 or less within 8 hours.
- Tumor Response using Immune-Related Response Criteria (irRC) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Tumor response defined following immune-related response criteria as 50% or greater decrease in tumor's linear dimension post treatment, compared to baseline using immune-related response criteria (irRC) which is a modified version of World Health Organization (WHO) criteria.
|Study Start Date:||January 2015|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: CXCR2 + NGFR T-cells
Cytoxan administered intravenously (IV) at 60 mg/kg/day over approximately 2 hours on Days -7 and -6. Mesna 60 mg/kg administered IV over 24 hours on Days -7 and -6. Fludarabine infused at 25 mg/m2 IV daily over approximately 15-30 minutes on Days -5 to -1. On day 0, all patients receive up to 1.5x10^11 T cells (including both CXCR2 and NGFR transduced TIL). TIL infused as an inpatient by IV over approximately 15-60 minutes. Twelve (12) to sixteen (16) hours after completing T cell infusion, all patients receive high dose interleukin-2 (IL-2) on an inpatient basis at standard dose of 720,000 IU/kg as an intravenous bolus over an approximate 15 minute period every 8-16 hours for up to 15 doses on Days 1 to 5, as tolerated.
60 mg/kg/day by vein on Days -7 and -6.
Other Names:Drug: Mesna
60 mg/kg by vein on Days -7 and -6.
Other Name: MesnexDrug: Fludarabine monophosphate
25 mg/m2 by vein on Days -5 to -1.
Other Names:Procedure: T cell Infusion
Participants receive up to 1.5x10^11 T cells by vein (including both CXCR2 and NGFR transduced TIL) on Day 0.Drug: IL-2
720,000 IU/kg by vein every 8-16 hours for up to 15 doses on Days 1 to 5.
Other Names:Other: Questionnaire
Questionnaire completion about health and quality of life one (1) time a year for up to 15 years. Questionnaire should take about 15 minutes to complete.
Other Name: Survey
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01740557
|Contact: Rodabe N Amaria, MD||713-792-2921|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rodabe N Amaria, MD||M.D. Anderson Cancer Center|