Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Health Network, Toronto
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have measurable, unresectable stage III or stage IV melanoma
Suitable tumor for collection
If tumor is suitable for collection, patient must be suitable for surgery
Patient must be 18 years of age or older
Performance status of ECOG 0 or 1
Life expectancy \> 5 months from date of consent of TIL evaluation
Willing to be tested for transmissible diseases
For patients with a history of allergy to penicillin, gentamycin, streptomycin, or anti-fungals, the ability to generate TILs will be confirmed with the cell manufacturing laboratory
Signed and dated the informed consent
No brain metastases or stable brain metastases for 3 months following definitive treatment.
Life expectancy \> 3 months from the date of consent for TILs treatment
TILs are suitable for use as determined by laboratory
More than 30 days since any prior systemic therapy at the time of the cell infusion, or more than six weeks since prior nitrosurea therapy. For patients with prior ipilimumab therapy, at least six weeks must elapse between the last ipilimumab dose and the start of study treatment. All side effects from previous treatment must have recovered to an acceptable grade level.
Adequate organ function
Must have positive EBV titres
Women of child-bearing potential must have a negative pregnancy test. Patients of both genders must be willing to practice birth control during treatment and for 6 months post completion of IL-2 treatment.
You may not be if
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
Clareo Health | Tumor-Infiltrating Lymphocytes And Low-Dose Interleukin-2 Therapy Following Cyclophosphamide And Fludarabine In Patients With Melanoma
