sodium selenite pentahydrate for Advanced carcinoma

Inclusion criteria

• {"criterion_text":"- Advanced malignant disease, stage III or IV.\n- A female participant is eligible for this study if she is one of the following: •\tof non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, or infertile due to previous chemotherapy) •\tof childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) Highly effective methods of contraception include one or more of the following: a.\tmale partner who is sterile (vasectomized) prior to the female study subject’s entry into the study and is the sole sexual partner for the female subject; b.\thormonal (oral, intravaginal, transdermal, implantable or injectable) c.\tan intrauterine hormone-releasing system (IUS) d.\tan intrauterine device (IUD) with a documented failure rate of < 1%.\n- Histologically or cytologically verified tumor.\n- Progressing tumor despite earlier treatment with all standard of care treatments for respective tumor\n- WHO performance status 0, 1 and 2.\n- 18 or more years of age.\n- Radiation therapy or chemotherapy should not have been given for a t least 3 weeks before start of selenite.\n- The patient must accept to give blood and urine samples for routine and for research purposes.\n- Written informed consent.\n- The patient must accept that the study treatment and the follow-ups within the study are performed at the phase 1 unit at Tema Cancer, Karolinska University Hospital."}

Exclusion criteria

• {"criterion_text":"- Dysfunction of heart (NYHA ≥2), kidney (cystatinC >1.60, if on limit Pt-eGFR<50), liver (bilirubin > 30) or other organs that might give a considerable increased risk for patient safety.\n- Pregnant or breast-feeding women\n- Patients with reproductive potential not implementing accepted and effective means of contraception.\n- Cancer-treatment within the previous 3 weeks. The patient can be included when 3 weeks have past since the latest treatment if still fulfilling all other criteria.\n- Impaired ability to cooperate.\n- The tumor size not possible to measure\n- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n- Ongoing treatment with antidepressants other psychotropic drugs that may cause confusion. The drug must be stopped at least 3 weeks before starting selenite treatment.\n- Medical history of obstacle in the pharynx giving risk for aspiration pneumonia if vomiting.\n- Brain metastases giving symptoms and symptomless brain metastases localised in the pons region. CT or MRI of the brain, not older than 6 weeks before start of treatment must be free from metastases. Patients with treated brain metastases (irradiation or surgery) and free from symptoms can be included.\n- Patients with known HIV/AIDS or hepatitis B/C with respect to increased risks for scientists working with research blood samples.\n- Allergies against previously used chemotherapy."}

Primary endpoints

• {"endpoint_text":"- The optimal dose, i.e., the dose with the best clinical response without DLT. Clinical response will be evaluated using RECIST 1.1 on CT scans taken before and after the selenite treatment. Toxicity will be measured according to the CTCAE V4.0 system (as in previous SECAR studies, to allow for direct comparisons).","definition_or_measurement_approach":"Clinical response evaluated using RECIST 1.1 on CT scans taken before and after selenite treatment; toxicity measured according to CTCAE V4.0; endpoint defined as dose with best clinical response without dose limiting toxicities (DLT)."}

Secondary endpoints

• {"endpoint_text":"- Tumor response to chemotherapy following selenite treatment as evaluated using RECIST 1.1 on CT scans taken before and after chemotherapy.","definition_or_measurement_approach":"Evaluated using RECIST 1.1 on CT scans taken before and after chemotherapy."}
• {"endpoint_text":"- Improvement of disease symptoms as measured by improvement in WHO performance status assessed before, during and after treatments","definition_or_measurement_approach":"Measured by change in WHO performance status assessed before, during and after treatments."}
• {"endpoint_text":"- Improvement of disease symptoms according to tumour markers or improvement of other abnormal laboratory results measured before, during and after treatments.","definition_or_measurement_approach":"Measured by tumour markers or other laboratory results collected before, during and after treatments."}
• {"endpoint_text":"- Description of the pharmacokinetics of selenium and selenite. Plasma, erythrocytes and urine for these analyses will be collected before, during and after the selenite infusion.","definition_or_measurement_approach":"Pharmacokinetics described from plasma, erythrocyte and urine samples collected before, during and after infusion."}
• {"endpoint_text":"- Correlation between plasma levels and erythrocyte levels of selenite and clinical responses and AE’s.","definition_or_measurement_approach":"Correlation analyses between plasma and erythrocyte selenite levels and clinical responses and adverse events."}
• {"endpoint_text":"- The effect of high dose selenite-infusion on immunological variables","definition_or_measurement_approach":"Assessment of immunological variables pre-, during and post-infusion (specific assays not detailed)."}
• {"endpoint_text":"- Overall survival as measured from the first selenite treatment day until death of any cause.","definition_or_measurement_approach":"Overall survival measured from first selenite treatment day until death from any cause."}

Sweden

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

15

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Sjöbergstiftelsen","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Cancerfonden","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Cancerföreningen i Stockholm","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Cancer-och Allergifonden","duties_or_roles":"Source of monetary support","organisation_type":""}