Phase 2 Stomach Cancer 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:

• The cancer must be measurable, spread to other parts of the body or unable to be surgically removed, and must carry a specific gene mutation called G12V in the KRAS, NRAS, or HRAS gene, confirmed by an approved laboratory test.
• People must have a specific immune system marker called HLA-A*11:01, confirmed by the NIH Department of Transfusion Medicine.
• The cancer diagnosis must be confirmed by the NCI Laboratory of Pathology.
• People must have already tried standard treatments for their advanced cancer without success, or the cancer returned after treatment — with specific prior treatment requirements depending on cancer type (colorectal, pancreatic, lung, ovarian, or prostate cancer); alternatively, people who have declined standard treatment may also be considered.
• People with 3 or fewer small brain tumours (under 1 cm) that are not causing symptoms may be eligible, including those who have had brain tumours surgically removed or treated with a focused radiation technique, provided the treated area has been stable for at least one month.
• People must be aged 18 to 72 years old.
• People must have a good general level of physical functioning, rated as ECOG 0 or 1 (meaning fully active or able to carry out light activity) (confirm with trial site).
• People must be willing to use birth control during the trial and for 12 months after finishing chemotherapy (for women) or 4 months after treatment (for men).
• Women who could become pregnant must be willing to have a pregnancy test before treatment starts.
• Blood test results must show no signs of HIV, hepatitis B, or active hepatitis C infection.
• Blood counts must meet minimum levels — including white blood cells, platelets, and haemoglobin — as confirmed by recent lab tests.
• Liver function test results must be within an acceptable range, and bilirubin levels must be below specified limits (a slightly higher limit applies for people with a condition called Gilbert's Syndrome).
• Kidney function must meet a minimum level, confirmed by a blood or urine test.
• Any previous cancer treatments must have been completed before joining the trial, with any related side effects having largely resolved.
• People must be willing and able to understand and sign a written consent form and a durable power of attorney document.
• People must be enrolled in a linked study called protocol 03C0277.

Who may not be able to join:

• People who have had large areas of their lungs treated with radiation.
• Women who are pregnant or breastfeeding.
• People currently taking systemic steroid medications.
• People with active infections requiring treatment, blood clotting disorders, or other serious ongoing medical conditions.
• People with a primary immune system disorder, such as Severe Combined Immunodeficiency Disease.
• People with active opportunistic infections (infections that occur when the immune system is weakened).
• People with a history of a severe allergic reaction to cyclophosphamide, fludarabine, or aldesleukin (medications used in the trial).
• People with a history of heart artery procedures (such as bypass or stenting) or symptoms of reduced blood flow to the heart.
• For people whose medical history prompts a heart assessment: a heart pumping function (LVEF) at or below 45% may make someone ineligible (confirm with trial site).
• For people whose medical history prompts a lung assessment: certain lung function measurements below specified thresholds may make someone ineligible (confirm with trial site).
• People currently participating in another clinical trial involving an experimental treatment.

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