Melanoma
A Phase I/II Study of IL-15 Administration Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen and Autologous Lymphocyte Transfer in Metastatic Melanoma
NCI-11-C-0170, NCT01369888
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Investigator(s): |
Steven A. Rosenberg, M.D., Ph.D.
Principal Investigator
Phone: 1-866-820-4505 (Toll Free)
ncisbirc@mail.nih.gov
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June A. Kryk, R.N.
Research Nurse
Phone: 1-866-820-4505
(Toll Free)
Fax: 301-451-1927
ncisbirc@mail.nih.gov
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Linda Williams, R.N.
Research Nurse
Phone: 1-866-820-4505
(Toll Free)
Fax: 301-451-1927
ncisbirc@mail.nih.gov
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Key Eligibility Criteria:
- Diagnosis of metastatic melanoma
- Measurable disease with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation
- ≥ 18 years of age
- ECOG ≤ 1
- No concurrent major medical illnesses or any form of immunodeficiency
- No contraindications for IL-15 (rhIL-15) administration
Study Outline:
- Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
- Patients undergo leukapheresis to obtain certain types of blood cells
- Generation of autologous young tumor infiltrating lymphocytes (TIL) cultures cultured from the patient’s tumor cells obtained either from a biopsy or during surgery
- Following successful generation of young TIL, admission to the NIH Clinical Center to begin treatment with a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine
- After completion of the preparative regimen, patients will receive the infusion of TIL and then begin IL-15 (rhIL-15) every day for up to 10 doses
- Return to the clinic for a physical exam, review of side effects, labs, and scans every
4–6 weeks for the first year, and then every 6 months
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 12/14/12
Updated: 6/19/12
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