Study of Lymphodepletion Plus Adoptive Cell Transfer With T-Cells Transduced With CXCR2 and NGFR Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT01740557|
Recruitment Status : Recruiting
First Posted : December 4, 2012
Last Update Posted : September 3, 2018
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn the side effects of T-cells injected with CXCR2 and NGFR when given in combination with chemotherapy (cyclophosphamide and fludarabine) and aldesleukin to patients with metastatic melanoma in an attempt to allow them to better localize the tumor. The safety of this combination will also be studied.
This is an investigational study. CXCR2 and NGFR T-cells is not FDA approved or commercially available. It is currently being used for research purposes only.
Cyclophosphamide is FDA approved and commercially available for the treatment of several types of cancer (such as leukemia, lymphoma, and breast cancer).
Fludarabine is FDA approved and commercially available for the treatment of B-cell chronic lymphocytic leukemia.
Aldesleukin is FDA approved and commercially available for the treatment of Metastatic melanoma or renal cell carcinoma.
The study doctor will tell you how the study drugs are designed to work.
Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Cytoxan Drug: Mesna Drug: Fludarabine monophosphate Procedure: T cell Infusion Drug: IL-2 Other: Questionnaire||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With T-Cells Transduced With CXCR2 and NGFR Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma|
|Actual Study Start Date :||January 28, 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
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.
60 mg/kg by vein on Days -7 and -6.
Other Name: Mesnex
Drug: Fludarabine monophosphate
25 mg/m2 by vein on Days -5 to -1.
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.
720,000 IU/kg by vein every 8-16 hours for up to 15 doses on Days 1 to 5.
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
- Toxicity of CXCR2 Transduced Tumor Infiltrating Lymphocytes (TIL) [ Time Frame: 6 weeks ]
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 ]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.
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): 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|