A Phase I Study Evaluating the Feasibility and Safety of Infusion of "Re-Stimulated" Autologous Tumor-Infiltrating Lymphocytes (TILs) Followed by Low-Dose Interleukin-2 Therapy in Metastatic Melanoma Patients
Inclusion Criteria
Inclusion Criteria (Eligibility for TIL Evaluation):
- 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
Inclusion Criteria (Eligibility for Treatment):
- Signed and dated the informed consent
- Must have measurable, unresectable stage III or stage IV melanoma
- No brain metastases or stable brain metastases for 3 months following definitive
treatment.
- Performance status of ECOG 0 or 1
- 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
- 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
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