A Phase 2 Study Using Short-Term Cultured Anti-Tumor Autologous
Lymphocytes Following A Non-Myeloablative Lymphocyte Depleting
Chemotherapy Regimen In Metastatic Melanoma
Principal Investigator: John P Hanson, Jr., M.D. Co-Investigator:
Jonathan Treisman, M.D.
Eligibility criteria
To be eligible for this clinical trial, patients must meet the
following criteria:
Melanoma that has spread in the body, with at least one tumor that
is removable for Y-TIL generation
Life expectancy greater than three months
18 years of age or older
Able and willing to sign an informed consent and durable power of
attorney
Able to perform activities of daily living
Previously treated with chemotherapy or high dose interleukin-2
unless ineligible or refused prior treatment
Melanoma that has spread to the brain is allowed, as long as it is
treated and stable for three months
Willing to practice effective birth control
Laboratory values within ranges acceptable for the study
Women of child bearing age may not be pregnant or breastfeeding
More than four weeks since any prior therapy
No systemic steroid therapy (topical steroids are allowed)
No active systemic infections or bleeding disorders
No active major medical illnesses of the heart or lungs
No immune system disease such as diabetes or rheumatoid arthritis
No primary immunodeficiency such as HIV or AIDS
No opportunistic infections (infections that take advantage of
immune system weakness)
No history of cardiac bypass surgery or heart attack
Additional eligibility criteria must be met at the time of screening.
