High grade osteosarcoma
Conditions
Interventions
fasudil hydrochloride hydrate as an IV infusion
fasudil hydrochloride hydrate
Sponsors
Fujita Nobuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Stage2A, 2B, 3,4, or recurrent high grade osteosarcoma. 2.14 to 64 years of age. 3.Sex; male or female 4.Performance status(ECOG); 0-1 5.With or without measurable disease. 6.Latest adequate organ function as proved by the following laboratory studies within 14 days prior to registration. Neutrophil count>=1,500 /mm3 Hemoglobin>=9.0 g/dL Platelet count>=100,000 /mm3 Total bilirubin=92% 7.Without symptomatic brain metastases and no spinal metastases requiring surgical treatment. 8.No grade 3 or more superior vena cava syndrome, pericardial effusion, pleural effusion, or ascitic fluid. 9.No surgical history within 28 days prior to registration. 10.Not received palliative palliative radiotherapy for metastasis (including gamma knife radiosurgery for brain metastases) within 14 days prior to registration. 11.For patients of child bearing potential: negative urine test within 14 days prior to registration. 12.Able to take oral medications. 13.Written informed consent obtained from the subject or the legally authorized representative.
Exclusion criteria
Exclusion criteria: 1.Latest adequate organ function as proved by the following laboratory studies within 14 days prior to registration. Hemoglobin 5 x ULN Total bilirubin > 3 x ULN 2.Has received chemotherapy, radiation therapy, or other medical therapies within 2 weeks prior to the first dose of Investigational Product. 3.With active bleeding. 4.History of myocardial infarction, angina unstable, congestive heart failure, cerebrovascular disorder (including transient ischaemic attack), pulmonary embolism, or active thromboembolism 5.Patient with uncontrolled Bronchial asthma. 6.Patient with a personal or family history of intracranial bleeding, known intracerebral aneurysms, Moyamoya disease or intracranial lesion on examinations performed within 7 days before first dose of Investigational Product. 7.Patient with hypotension. 8.Patient with hepatic disorder. 9.Patient with renal disorder. 10.Patient with pleural effusion or ascites. 11.History of Cardiac dysfunction. 12.Patients with serious hypersensitivity to methotrexate, adriamycin and cisplatin. 13.Has undergone thoracotomy or laparotomy within 4 weeks prior to the first dose of Investigational Product. 14.Pregnant, lactating or planning pregnancy. 15.Deemed ineligible as determined by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity Maximum tolerated dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Objective Response Rate Progression free survival Pharmacokinetic parameters | — |
Contacts
Public ContactNobuyuki Fujita
Fujita Health University Hospital
Outcome results
None listed