Patient with brain metastases from cancer of any histology. A phase I trial. MedDRA version: 12.1 Level: LLT Classification code 10006128 Term: Brain metastases
Conditions
Interventions
Trade Name: Bleomycin "Baxter"
Product Name: bleomycin "Baxter"
Pharmaceutical Form: Powder for infusion*
Sponsors
Oncology Department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients > 18 years. 2. ECOG performance status 10 millimetre and 3.0 x 109/l, thrombocytes > 75 x 109/l, hemoglobin > 7 g/dl. o Hepatic: Alkaline phosphate, ALAT or ASAT and bilirubin must not be increased more than 2 times, pp > 40, APTT in normal range. Medical correction is allowed, e.g. correction of low pp using vitamin K. o Renal: if creatinin > 150 micromolar do a GFR examination (Chrom-EDTA). If Chrom-EDTA clearance is less than 48 ml/min, treatment cannot be offered 15. Patients must not have a blood pressure (BP) over 180 mm Hg systolic and 110 mm Hg diastolic. In the case of BP>180/110 mm Hg, this can be medically corrected, and the patient can be included, when the BP is below this threshold. 16. Sexually active men and women of childbearing potential must use adequate birth control during this study and 6 month after the administration of bleomycin (contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches). 17. Participating patients must be able to understand the patient information (‘Deltagerinformation’). 18. Participating patients must have signed a written informed consent and power of attorney prior to inclusion in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute lung infection. 2. Previous bleomycin treatment with more than 200.000 Units/m2. 3. Previous allergic reaction to bleomycin. 4. Allergy towards the sedation used. 5. Pregnancy or breastfeeding. Pregnancy in fertile women is excluded by a measurement of HCG in a blood sample. Sterile or infertile women are excluded from the requirement to use anticonception. To be considered sterile or infertile, the patient must have undergone surgical sterilization (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovarectomy) or be post-menopausal defined as the absence of menstruation. 6. Treatment with G-CSF (Granulocyte Colony Stimulating Factor) or other cytokines. 7. Lung diffusion capacity (DLCO) below normal. DLCO is to be performed in case of suspected (anamnestic or clinical) reduced lung function. 8. Physician’s assessment that meningeal carcinomatosis (leptomeningeal disease) is a likely cause of the patient’s symptoms. 9. Treatment with anticoagulants (marevan, marcumar, innohep). If the physician finds it safe to pause the administration of anticoagulants the patient can be included. This decision should be made using the Neurosurgery Department’s Guideline. 10. Allergic to nickel, chromium or cobalt. 11. Participation in another clinical study with an experimental drug up to 4 weeks prior to inclusion. 12. Illnesses, medical, social or physiological, that may affect the patient’s ability to understand the patient information and participate in the follow-up. 13. Other serious systemic illnesses (i.e. active infection, abnormal EKG) that the investigator finds may affect the patient’s safety and/or ability to complete the study. 14. Treatment with Immunosuppressant drugs such as methotrexat and cyclosporine during the study. Treatment with prednisolone is accepted during the study. 15. Implanted pacemaker, defibrillators or hearth valve prosthetics. 16. Implanted devices such as neurostimulators, eartransplants, insulinpump, metallic tracheostomy. 17. Catheters with metal such as Port á cath, Swan Ganz, P-dialysis cath., ventriculoartrial and -peritoenal shunts, bladder cath. with thermo measurement. 18. Metallic clips/prosthetics/magnets from surgery such as neuro- or abdominal clips, tooth- or other prosthetics. 19. Disorganised metallic material such as metal fragments in the eyes, shrapnel, gun shot injuries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint is safety of the trial treatment, electrochemotherapy for brain metastases. This is evaluated by regularly registrations of adverse events (serious adverse events and adverse events) using the CTCAE criteria version 4.0.;Secondary Objective: The secondary endpoint is efficacy of the trial treatment, electrochemoterapy for brain metastases. This is evaluated by tumor response on MRI scans of the brain using the RECIST criteria. Performance in basic Activities of Daily Living (ADL) measured by the Barthel Index.;Primary end point(s): The primary endpoint for this dose-escalating fase I clinical trial is safety of the trial treatment. This is evaluated by regularly registrations of adverse events (Serious Adverse Events and Adverse Events) using the CTCAE criteria version 4.0. Determination of dose limiting toxicity (DLT) is defined as any CTCAE grade 4 toxicity. | — |
Countries
Denmark
Outcome results
None listed