Early Phase 1 Melanoma Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 years or older.
• People who have been diagnosed with solid tumours that have spread, come back, or cannot be surgically removed.
• People with a life expectancy of at least 3 months.
• People who are well enough to carry out basic daily activities, as measured by a standard medical scale called the ECOG scale (scores 0–2) (confirm with trial site).
• People whose heart, liver, kidneys, and other organs are functioning adequately, as determined by standard blood tests reviewed by the trial doctor.
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining the trial, and must agree to use reliable contraception throughout the trial and for 30 days after the last treatment dose.
• Women considered unable to become pregnant must have a documented history of menopause (at least 1 year without periods), tubal ligation, or hysterectomy.
• People who are willing and able to follow a special low-methionine diet as set out by the trial protocol (methionine is an amino acid found in many foods).
• People, or their legally authorised representatives, who provide written informed consent before any trial-related procedures begin.
• People who are able to receive standard cancer treatment given throughout the body (systemic therapy).

For people with glioma (a type of brain tumour) specifically:

• People with a confirmed tissue diagnosis of either newly diagnosed grade 2–3 glioma, or recurrent glioma of any grade.
• People who are able to receive radiation therapy and/or chemotherapy as part of their treatment.

Who may not be able to join:

• People with brain metastases (cancer that has spread to the brain) that are uncontrolled or causing symptoms. Note: people whose brain metastases have been treated and are not causing symptoms may still be considered eligible, including those who need steroids (confirm with trial site).
• People with serious uncontrolled illnesses, including active infections needing systemic treatment, severe heart conditions such as a heart attack within the past 6 months, uncontrolled chest pain, serious heart failure, or significant heart rhythm problems, or uncontrolled diabetes.
• People with serious conditions that affect how the body processes amino acids or absorbs nutrients, including severe liver disease such as cirrhosis, inherited metabolic disorders affecting how the body processes certain amino acids, or severe gut conditions such as active inflammatory bowel disease or short bowel syndrome.
• People who have had major surgery within 4 weeks before joining the trial (minor procedures such as biopsies may be acceptable at the trial doctor's discretion).
• People who have another cancer that requires active treatment during the trial or that may interfere with the trial treatment.
• People who are pregnant or breastfeeding.
• People with severe malnutrition or significant nutritional deficiencies, as determined by the trial doctor.
• People with a history of substance abuse or dependency within the past 6 months that, in the trial doctor's opinion, would affect their ability to follow trial requirements.
• People with chronic kidney disease at an advanced stage (stage 3b or higher).
• People with psychiatric conditions that would affect their ability to give informed consent or follow trial requirements, as determined by the trial doctor.
• People with known allergies or intolerances to low-methionine foods.
• People with any medical or surgical condition that, in the trial doctor's opinion, would make following the low-methionine diet unsafe or not practical.

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