Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 36
Summary
- Conditions
- Metastatic Melanoma
- Stage III Cutaneous Melanoma AJCC v7
- Stage IIIA Cutaneous Melanoma AJCC v7
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To assess the feasibility and safety of autologous transforming growth factor beta (TGFb) resistant (DNRII transduced) and NGFR transduced tumor infiltrating lymphocytes (TIL) in patients with metastatic melanoma. SECONDARY OBJECTIVES: I. To determine the survival and immune f...
PRIMARY OBJECTIVES: I. To assess the feasibility and safety of autologous transforming growth factor beta (TGFb) resistant (DNRII transduced) and NGFR transduced tumor infiltrating lymphocytes (TIL) in patients with metastatic melanoma. SECONDARY OBJECTIVES: I. To determine the survival and immune function of TGFb resistant (DNRII transduced) TIL in vivo. II. To assess the anti-tumor effects of TGFb resistant (DNRII transduced) TIL. OUTLINE: This is a dose-escalation study of TGFb DNRII-transduced autologous TIL and nerve growth factor receptor (NGFR)-transduced autologous T lymphocytes. Patients receive cyclophosphamide intravenously (IV) over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0. Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses). After completion of study treatment, patients are followed up at 6 and 12 weeks, every 3 months for 1 year and then yearly for 10 years.
Tracking Information
- NCT #
- NCT01955460
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Rodabe N Amaria M.D. Anderson Cancer Center