Phase 2 Ovarian 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:

• People with measurable, metastatic cancer (cancer that has spread) of one of these types: upper or lower gastrointestinal, liver/bile duct, urinary/reproductive system, breast, ovarian/uterine, or hormone-related cancers including neuroendocrine tumours — and who have at least one tumour that a surgeon could safely remove, ideally using keyhole surgery.
• People whose cancer diagnosis has been confirmed by the NCI Laboratory of Pathology.
• People whose cancer has stopped responding to standard approved treatments — specifically: people with metastatic colorectal cancer who have received oxaliplatin or irinotecan; people with liver cancer (hepatocellular carcinoma) who have received sorafenib (Nexavar®); and people with breast or ovarian cancer who have tried and not responded to both first- and second-line treatments, including at least one second-line chemotherapy.
• People with 3 or fewer small brain tumours (each less than 1 cm across) that are not causing symptoms, or people who have had brain tumours surgically removed, or people whose previously treated brain tumours have been clinically stable for at least one month after treatment.
• People aged 18 to 72 years old.
• People who are generally well enough to carry out daily activities with little or no limitation (ECOG performance status 0 or 1, confirm with trial site).
• People of all sexes who are willing to use birth control from the time of joining the trial until 12 months after finishing the chemotherapy portion of treatment (or 4 months after treatment for people who can father children).
• People who are capable of becoming pregnant must have a negative pregnancy test before treatment begins, due to potential risks to a foetus.
• People who test negative for HIV antibodies.
• People who test negative for hepatitis B and hepatitis C — if a hepatitis C antibody test comes back positive, a further test must confirm that the virus is not actively present in the blood.
• People whose blood counts meet the required levels: adequate white blood cells, neutrophils (infection-fighting cells), platelets, and haemoglobin (a blood transfusion to reach the haemoglobin level is permitted).
• People whose liver enzyme levels (ALT/AST), kidney function (creatinine), and bilirubin levels fall within the acceptable ranges specified by the trial — people with a condition called Gilbert's Syndrome have a slightly different bilirubin limit (confirm with trial site).
• People who have completed any prior systemic treatment before enrolling, and whose side effects from any recent minor surgery or limited radiotherapy (within 4 weeks before joining) have largely resolved.
• People who are able to understand the trial and are willing to sign a written consent form and a durable power of attorney document.
• People who are also enrolled in a related study (protocol 03-C-0277).

Who may not be able to join:

• People who are pregnant or breastfeeding, due to potential risks to the baby.
• People currently taking steroid medications systemically (throughout the body).
• People with active infections requiring treatment, blood clotting disorders, or other serious uncontrolled medical conditions.
• People with an advanced primary tumour that is causing or at risk of causing a blockage, perforation, or bleeding, or who depend on blood transfusions.
• People with any form of primary immune system deficiency, such as Severe Combined Immunodeficiency Disease or AIDS.
• People with a history of serious autoimmune disease affecting a major organ.
• People who have experienced severe (grade 3 or 4) immune-related side effects in a major organ that were linked to prior immunotherapy treatment (anti-PD-1/PD-L1 therapy).
• People with active opportunistic infections (infections that occur when the immune system is weakened).
• People who have had a severe allergic reaction to cyclophosphamide, fludarabine, or aldesleukin (medicines used in this trial).
• People with a history of heart artery procedures (coronary revascularisation) or symptoms of reduced blood supply to the heart.
• People whose heart pumping function (LVEF) has been measured at 45% or below, where a cardiac evaluation was clinically indicated (confirm with trial site).
• People with hepatocellular carcinoma (liver cancer) who have a Child-Pugh score of B or C, indicating significant underlying liver damage (confirm with trial site).
• People whose lung function test (FEV1) shows 50% or below of expected capacity, where a lung evaluation was clinically indicated (confirm with trial site).
• People who are currently taking part in any other clinical research trial involving investigational treatments.

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