Overview

Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors

Status:
Completed

Trial end date:
2018-01-06

Target enrollment:
0

Participant gender:
All

Summary

The patient was given a daily dose of apatinib 500mg (or based on weight). Individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rongjie Tao

Treatments:

Apatinib
Temozolomide

Criteria

Inclusion Criteria:

- (1) 18 years < the age of patients > 70 years. (2) Karnofsky performance scale (KPS) ≥
60. (2) Histologically confirmed diagnosis of GBM World Health Organization [WHO]
Grade IV. (3) They were required to have measurable or evaluable disease by magnetic
resonance imaging (MRI) confirmation and a minimum life expectancy of 8 weeks. (4)
Definition of relapse: all patients must have progressive disease on MRI defined by
Response Assessment in Neuro-Oncology (RANO) criteria after the standard Stupp
protocol. The time interval for the start of treatment was at least 12 weeks from
prior radiotherapy unless there was either histopathologic confirmation of recurrent
tumor or new contrast enhancement on MRI outside of the radiotherapy treatment field.
(5) Adequate bone marrow function (leukocyte count ≥ 4000/μL, neutrophil count
≥1500/µL, platelet count ≥100 000/µL, hemoglobin ≥8.0g/dL), adequate renal function
(serum creatinine ≤ 150μmol/L, 24 hours urine protein ≤3.4g), and liver function
(total bilirubin ≤34μmol/L and aspartate and alanine aminotransferase ≤120U/L).

Exclusion Criteria:

- (1) extracranial metastatic disease, (2) Gliadel wafer treatment, (3) severe
cardiopulmonary insufficiency, (4) status epilepticus, (5) pregnancy, (6)
gastrointestinal bleeding, (7) uncontrolled blood pressure with medication (>140/90 mm
Hg), (8) swallowing difficulties. (9) HIV positivity with a combination antiretroviral
therapy.