Phase II Study Evaluating The Infusion Of Autologous Tumor-Infiltrating Lymphocytes (TILs) And Low-Dose Interleukin-2 (IL-2) Therapy Following A Preparative Regimen Of Non-Myeloablative Lymphodepletion Using Cyclophosphamide And Fludarabine In Patients With Metastatic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Cyclophosphamide
- Conditions
- Metastatic, Stage III or Stage IV, Melanoma
- Sponsor
- University Health Network, Toronto
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Clinical response to treatment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a phase II clinical study for patients with metastatic (the cancer has spread to other parts of the body) melanoma. Patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down.
Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This study will see how useful this regimen is in treating metastatic melanoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Requiring systemic steroid therapy
- •HIV positive
- •With active hepatitis B or hepatitis C, syphilis, or HTLV
- •Must not have any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, uncontrolled psychiatric disorders, or other conditions that may affect following study procedures.
- •Have no active underlying cardiac illnesses defined by positive stress test, LVEF\<40% or ongoing life-threatening arrhythmias
- •Abnormal lung function test
Arms & Interventions
Cyclophosphamide and Fludarabine followed by TILs and IL-2
Cyclophosphamide, i.v., 60mg/kg per day for 2 days and Fludarabine, i.v., 25mg/m2 per day for 5 days; then Tumor-Infiltrating Lymphocytes, i.v., 1x10\^10 - 1.6x10\^11 cells and Low-Dose Interleukin, i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Intervention: Cyclophosphamide
Cyclophosphamide and Fludarabine followed by TILs and IL-2
Cyclophosphamide, i.v., 60mg/kg per day for 2 days and Fludarabine, i.v., 25mg/m2 per day for 5 days; then Tumor-Infiltrating Lymphocytes, i.v., 1x10\^10 - 1.6x10\^11 cells and Low-Dose Interleukin, i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Intervention: Fludarabine
Cyclophosphamide and Fludarabine followed by TILs and IL-2
Cyclophosphamide, i.v., 60mg/kg per day for 2 days and Fludarabine, i.v., 25mg/m2 per day for 5 days; then Tumor-Infiltrating Lymphocytes, i.v., 1x10\^10 - 1.6x10\^11 cells and Low-Dose Interleukin, i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Intervention: Tumor-Infiltrating Lymphocytes
Cyclophosphamide and Fludarabine followed by TILs and IL-2
Cyclophosphamide, i.v., 60mg/kg per day for 2 days and Fludarabine, i.v., 25mg/m2 per day for 5 days; then Tumor-Infiltrating Lymphocytes, i.v., 1x10\^10 - 1.6x10\^11 cells and Low-Dose Interleukin, i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Intervention: Low-Dose Interleukin
Outcomes
Primary Outcomes
Clinical response to treatment
Time Frame: 6 weeks after treatment
Secondary Outcomes
- Number occurrences and severity of side effects(Starting at first dose of study treatment up to 10 years)
- Number of patients with an immunity and no immunity to the study treatment(From start of study up to 10 years)