Phase 1 Pancreatic 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:

• Adults aged 18 or older.
• People diagnosed with stage IV pancreatic cancer or stage IV breast cancer (including those whose cancer responded completely to prior chemotherapy).
• People whose doctor estimates they have at least 6 months life expectancy.
• People whose overall health is not severely limited by conditions other than their cancer, as assessed by the trial doctor.
• People with a general functioning level of at least 60% on a standard medical scale called the Karnofsky score (confirm with trial site).
• People who have not received chemotherapy in the 2 weeks before joining the trial.
• People who have previously had surgery or ablation to remove the primary tumour, or those who have not — either is acceptable.
• People who have had prior surgery must be at least 28 days past their operation, with wounds healed and major complications resolved.
• People who have previously received chemotherapy and/or PARP inhibitor drugs.
• People whose cancer can be measured or detected using standard imaging criteria (confirm with trial site).
• People who carry an inherited (germline) harmful mutation in the BRCA1, BRCA2, or PALB2 gene, confirmed by a certified laboratory.
• People who have a tumour-only (somatic) harmful mutation in BRCA1, BRCA2, or PALB2, confirmed by a certified laboratory, with both copies of the gene affected, and with agreement from the trial's Genetics Review Committee.
• People without a BRCA1, BRCA2, or PALB2 mutation who have received at least 16 weeks of first-line platinum-based chemotherapy (or FOLFIRI after switching from FOLFIRINOX due to side effects) with no sign of treatment failure.
• People with pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma, and where surgery has been performed, no disease progression since surgery.
• People with HER2-negative breast adenocarcinoma, of any sex.
• People whose cancer diagnosis has been confirmed through tissue or cell testing.
• People whose cancer spread (metastasis) has been confirmed through tissue or cell testing, unless the trial doctor determines a biopsy is not needed.
• Women of childbearing potential who agree to use two barrier methods of contraception simultaneously (such as a diaphragm plus spermicide, or condom plus spermicide — oral or injectable contraceptives are not permitted), or who practise true, consistent abstinence, from the time of signing consent until 6 months after the last dose of the study drug melphalan.
• Male participants who agree to use effective barrier contraception plus a second contraceptive method, or who practise true, consistent abstinence, from the time of signing consent until 6 months after the last dose of melphalan — unless in a monogamous relationship with a partner who cannot become pregnant.

Who may not be able to join:

• People whose cancer is progressing rapidly or who show signs of quickly worsening symptoms, as assessed by the trial doctor.
• People with a blocked bile duct.
• People with a current active bile duct infection (cholangitis), noting that having a biliary stent in place alone does not exclude participation.
• People with a history of one episode of bile duct infection where fewer than 30 days have passed since finishing antibiotic treatment.
• People with a history of multiple episodes of bile duct infection who, after review by the trial team and sponsor, are considered unsuitable due to the risk of recurrence.
• People with high blood pressure in the portal vein of the liver (portal hypertension), including a specific form called sinistral portal hypertension.
• People with major blockage or closure of key blood vessels near the liver or pancreas (such as the portal vein or superior mesenteric artery or vein).
• People with a clinically significant build-up of fluid in the abdomen or around the lungs caused by cancer, as assessed by the trial doctor.
• People with cancer spread to the heart or eye.
• People who received chemotherapy for a different cancer within the past year where there is more than a 30% chance of that cancer coming back, as assessed by the trial doctor.
• People with known or suspected cancer spread to the brain or spinal cord.
• People with heart pumping function below 45% (or significantly below the normal range) on a heart scan.
• People with clinically significant structural heart problems or blood vessel disease.
• People who have had a heart attack in the 6 months before joining; or who have severe heart failure, angina, uncontrolled irregular heartbeat, or signs of heart strain on an ECG.
• People with a significantly prolonged heart rhythm interval on an ECG (above 0.45 seconds in males or 0.47 seconds in females).
• People with severe high blood pressure, defined as a history of hypertensive crisis or emergency in the past year, or consistently very high blood pressure readings (systolic above 165 mmHg or diastolic above 110 mmHg). Note: well-controlled past severe hypertension or hypertension caused by a medicine that has since been stopped does not exclude participation. Having a pacemaker also does not exclude participation.
• People with other clinically significant heart or blood vessel conditions.
• People with a history or signs of lung scarring conditions such as pneumonitis or pulmonary fibrosis.
• People who smoke and are unwilling to stop for the duration of the trial.
• People with significantly reduced lung function based on breathing tests (below 50% of expected levels).
• People with a total bilirubin level more than twice the upper normal limit (except people with a condition called Gilbert's Disease may exceed this limit).
• People with liver enzyme levels (ALT or AST) more than 2.5 times the upper normal limit.
• People with elevated alkaline phosphatase (more than 2.5 times the upper normal limit) together with an elevated GGT level.
• People with a blood albumin (protein) level below 3.0 g/dL.
• People with clinical signs of a condition causing damage to the small veins in the liver (sinusoidal obstruction syndrome).
• People with consistently low kidney filtering function (below 50 ml/min/1.73m²).
• People with other clinically significant kidney disease.
• People with a condition where the body destroys its own red blood cells (hemolytic anaemia).
• People with a family history of catalase enzyme deficiency, or a personal history of a severe reaction to hydrogen peroxide suggesting this deficiency, unless testing has confirmed the deficiency is not present.
• People with signs of bone marrow not functioning adequately, as judged by the trial doctor.
• People with a haemoglobin level below 9 g/dL (a measure of red blood cell levels).
• People with a deficiency of the enzyme G6PD, confirmed by blood testing below the normal range.
• People with pre-existing bleeding disorders or blood clotting problems.
• People who are pregnant.
• People who are breastfeeding and unwilling to stop.
• People with Wilson's disease (a condition involving copper build-up in the body).
• People with primary or secondary haemochromatosis (a condition involving iron build-up in the body).
• People with a HbA1c level above 9% (a measure of long-term blood sugar levels).
• People with high uric acid levels that have not responded to treatment.
• People with plasma oxalate levels above 10 µM that have not responded to measures to lower them.
• People with a history of clinically significant high oxalic acid levels or related complications.
• People with a prior or current hepatitis B or C infection.
• People with HIV infection or who test positive for HIV.
• People with an active, clinically significant bacterial, viral, or fungal infection.
• People with a history of carrying a highly resistant "superbug" that poses a serious infection risk if white blood cell counts drop.
• People with an uncontrolled seizure disorder.
• People who have previously received radiation therapy where a significant volume or dose was delivered to normal liver or lung tissue (confirm specific limits with trial site).
• People with a significant allergy or other reason they cannot receive the study drugs BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or any ingredients within those drugs.
• People who have taken certain medications that affect how BCNU is processed in the body (specific CYP2b6 inducers including phenobarbital, carbamazepine, rifampicin, phenytoin, sulfinpyrazone, or verapamil) within 21 days before planned BCNU treatment.
• People who have used disulfiram (Antabuse) within 30 days before planned ethanol administration in the trial.
• People currently using immunosuppressive medications on an ongoing basis (such as methotrexate, cyclosporine, or corticosteroids).
• People who have previously had a bone marrow stem cell transplant.
• People who have had prior radiation to the brain, kidneys, pelvis, or digestive tract, or treatment with yttrium-90 — except as adjuvant (preventive) treatment for breast or pancreatic cancer.
• People who have previously been treated with bleomycin or BCNU.
• People who have, within the past 30 days, received a drug not approved by the FDA for any use.
• People who still have side effects above a mild level from prior chemotherapy that have not resolved (with the exception of hair loss and moderate nerve-related side effects), unless the trial doctor considers these not clinically significant.
• People currently receiving any other cancer treatment.
• People with a serious underlying medical or psychiatric condition that the trial doctor believes would interfere with safe participation.
• People who are unwilling or unable to follow the study requirements.
• People who are unwilling to receive ethanol as part of the trial treatment.

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