Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors

Efficacy and Safety Clinical Trial

Official title:

Efficacy and Safety of Apatinib Combined With Dose-dense Temozolomide in Recurrent Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660761
• Other study ID #: ShandongCHI005
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2016
• Est. completion date: January 6, 2018

Study information

• Verified date: April 2019
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Brain MRI+MRS was examined every 3 months; Blood routine, urine routine and liver and kidney function were examined once a week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 6, 2018
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy and Safety

Intervention

Drug:
• apatinib
The patient was given a daily dose of apatinib 500mg (or based on weight). For adult, the dose of apatinib was prescribed with 425 mg or 500 mg per day and four weeks for a cycle. The dosage was modified to 250 mg if patients experienced ?grade 2 hematologic adverse events, hand and foot syndrome, proteinuria, fecal ocular blood, or grade 3/4 hypertension, or other grade 3/4 adverse events. Apatinib was administrated until disease progression, unacceptable toxicity or death.
• temodar
dose-dense temozolomide (100 mg/m2 , 7 days on with 7 days off ) , 28d

Locations

Country	Name	City	State
China	Neurosurgery, Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Rongjie Tao

Country where clinical trial is conducted

China, 

References & Publications (2)

Kasper H. [The supplying of vitamin A after pancreatectomy]. Med Welt. 1968 Jan 20;3:178-80. German. — View Citation

Potapova TV, Sharovskaia IuIu, Kovalev SA, Mittel'man LA, Chailakhian LM. [Effect of the ion composition of the surrounding medium on membrane potentials of L cells]. Tsitologiia. 1972 Nov;14(11):1335-41. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment	Response were evaluatedevery 1-3 months with Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) usingdynamic contrast enhancement magnetic resonance imaging (MRI) or computed tomography (CT). Complete response (CR) was defined as complete disappearance of target lesions and maintaining = 4 weeks; partial response (PR): = 30% reduction in maximum diameterof tumor and keepingstable = 4 weeks; progressive disease (PD):>20% increase in bidimensionalmeasurements of the lesions, or emerging one or more newlesions; stable disease (SD): criteria for CR, PR and PDnot met.PFS was defined as the initial treatment to the disease progression or the date of death.	up to 3 months
Secondary	Median non-progress survival (PFS)	Median non-progress survival (PFS)	up to 12 months