high-grade spinal cord glioma
Conditions
Interventions
Dose escalation cohort 1:Dose escalation cohort 1: 450 mg, bid, orally. D1-D168
Dose escalation cohort 2:Dose escalation cohort 2: 600 mg, bid, orally. D1-D168
Dose escalation cohort 3:Dose escalation cohort 3: 750 mg, bid, orally. D1-D168
Dose expansion cohort:Dose expansion cohort: 600 mg, bid, orally. D1-D168
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be eligible for the trial, all of the following eligibility criteria must be met: 1. The age of the subjects was >=18 years old and =60; b) Dose expansion phase: McCormick scale for intraspinal tumors =3 months according to the investigator's judgment; 7.fertile women: negative serum pregnancy test; 8. Patients of childbearing age agree to use contraception for at least 3 months from screening until the last treatment. Childbearing age was defined as not having been surgically sterilized (male or female) or not having amenorrhea for more than 1 year (female only).
Exclusion criteria
Exclusion criteria: Anyone who meets any of the following criteria is excluded: 1. Allergic, or known history of allergy to porphyroselenin tablets, porphyroselenin tablets analogues, or any component of porphyroselenin tablets or related preparations, who are judged by the investigator to be ineligible for enrollment; 2. patients with mental or psychological disorders who are unable to cooperate with the treatment and efficacy evaluation; 3. patients who were treated with any other investigational drug or enrolled in a clinical trial of any medical device within 3 months before screening; Other conventional antitumor therapies for spinal cord glioma in a nonexperimental design were received within 1 month before screening; 4. co-infection, active infection, fever of unknown origin; 5. oxygen saturation 2.5 times the upper limit of normal; Total bilirubin >=50µmol/L; C. Renal function: serum creatinine >=90µmol/L; D. Infectious disease examination: Active hepatitis B (HBV-DNA test if HBsAg or HBcAb was positive, HBV-DNA higher than the upper limit of the test was not allowed), active hepatitis C (HCV-RNA test if HCV antibody was positive, HCV-RNA higher than the upper limit of the test was not allowed), and active hepatitis C (HBV-DNA test if hbsag or HBcab was positive, HCV-DNA test was not allowed). Or people with human immunodeficiency virus infection (defined as HIV antibody positivity), or positive for active syphilis; E. Thyroid ultrasound examination with thyroid imaging reporting and Data system (TIRADS) >= grade 3 (item E only for the dose-escalation phase); 15. the subject was unable to complete the radiotherapy process required by the protocol; 16. imaging suggested that the subject had tumor CSF dissemination/metastasis/colonization, or the subject had tumor compression symptoms such as respiratory depression; 17. any other ineligibility factor that, in the opinion of the investigator, may affect adherence to the protocol, interfere with the interpretation of the study results, or expose the subject to risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Serious Adverse event;Adverse drug reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;3 months survival rate, 6 months survival rate;Progression-free survival at 12 months;Overall Survival;Progression free survival;Tumor volume;Objective response rate;JOA rating scale;McCormick scale for intraspinal tumors;SF-36 Quality of life questionnaire;Numeric Rating Scale (NRS) for cancer pain;Kanofsky's score; | — |
Countries
China
Contacts
Public ContactQiuxiaoguang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed