Phase 2 Melanoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been confirmed by laboratory testing to have melanoma that cannot be surgically removed (Stage III/IV) or that has spread to other parts of the body — including common skin melanoma, acral melanoma (found on palms, soles, or nail beds), mucosal melanoma (found in body cavities like the mouth or sinuses), or eye melanoma.
• People whose melanoma has stopped responding to, has not responded to, or who could not tolerate at least one standard treatment — such as certain immunotherapy drugs or, for some melanoma types, targeted therapies.
• People who have finished any previous cancer treatment at least 4 weeks before the start of a preparatory treatment used in this trial, and whose side effects from past treatments have largely resolved.
• People aged 18 or older. Those aged 65 and over may need a heart health evaluation before being considered — details depend on overall health and fitness level. People over 75 may still be considered if they are in good general health with no major medical conditions (confirm with trial site).
• People with a general health and activity level rated as fully active or able to do light work (this is measured using a standard medical scale called ECOG — confirm with trial site).
• People with healthy enough organ function (such as kidneys, liver, and bone marrow) as defined by the trial's specific requirements (confirm with trial site).
• People who test negative for HIV, hepatitis B, and hepatitis C.
• People who have brain tumours related to their melanoma, provided those tumours have already been treated with targeted radiation or surgery and have been stable for at least 4 weeks.
• Women of childbearing potential who test negative for pregnancy before joining.
• People of any sex who are willing to use effective birth control from the screening period until at least 1 year after the last study treatment (for females) or 6 months (for males).
• People who are able to understand the study and are willing to sign a consent form agreeing to participate.
• People who have at least one tumour that can be surgically removed to prepare the treatment cells, and at least one other measurable tumour remaining after that removal, so that treatment response can be tracked.

Who may not be able to join:

• People with a current or past history of heart disease caused by reduced blood flow to the heart, or significant irregular heart rhythms — unless a heart evaluation clears them as low or acceptable risk.
• People with conditions that weaken the immune system, either from birth (such as severe combined immunodeficiency) or acquired (such as HIV/AIDS).
• People who are pregnant, as the treatments used carry known risks to a developing baby. People who are breastfeeding would also need to stop breastfeeding if enrolled.
• People currently taking steroid medications above a low daily dose (equivalent to more than 10mg of prednisone per day), or other medicines that suppress the immune system — though tapering steroids to the lower dose before treatment may be allowed (confirm with trial site).
• People who have had a serious allergic reaction to specific drugs used in the trial, including cyclophosphamide, fludarabine, or IL-2.
• People with significantly reduced heart pumping function, or whose heart condition limits even light daily activity (confirm with trial site).
• People with significantly reduced lung function, based on specific breathing tests — unless recent testing already shows stable lung health.
• People who, in the trial doctor's judgement, have a health condition that would make participation too risky, or who may not safely be able to complete the steps involved in the trial.
• People with an active infection currently requiring antibiotic treatment.
• People with active autoimmune diseases that currently need treatment with high doses of steroids, immune-suppressing biologic drugs, or certain arthritis-related medicines.
• People who have previously received a live cell therapy treatment — unless the lead trial doctor gives specific written approval.

Important: Always verify eligibility with the trial site directly before applying.