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Apatinib in Recurrent or Refractory Intracranial Central Nervous System Tumorsmalignant Glioma

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ClinicalTrials.gov Identifier: NCT03660761
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Rongjie Tao, Shandong Cancer Hospital and Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Efficacy and Safety Drug: apatinib Drug: temodar Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single arm
Masking: None (Open Label)
Masking Description: Open Label (Subject)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Apatinib Combined With Temozolomide in Recurrent or Refractory Intracranial Central Nervous System Tumors
Actual Study Start Date : March 3, 2016
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : January 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: apatinib 500mg 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 125 mg and 250 mg in 1-5 years old and 5-18 years old, respectively.

Drug: temodar
200mg/m2, po, d1-5, 28d




Primary Outcome Measures :
  1. Response to treatment [ Time Frame: up to 3 months ]
    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.


Secondary Outcome Measures :
  1. Median non-progress survival (PFS) [ Time Frame: up to 12 months ]
    Median non-progress survival (PFS)



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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • performance status ≥60, life expectancy ≥2 months, and 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). Patients were not administrated with marrow suppressive chemotherapy within 4 weeks (6 weeks for nitrosureas) and biologic agents within 2 weeks. To stratification analysis, the status of VEGFR-2 of patients were tested in the date of data collection..

Exclusion Criteria:

  • multiple primary cancers, severe cardiopulmonary insufficiency, status epilepticus, pregnancy, gastrointestinal bleeding.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660761


Locations
China, Shandong
Neurosurgery, Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Sponsors and Collaborators
Rongjie Tao

Publications of Results:
Responsible Party: Rongjie Tao, Clinical Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03660761     History of Changes
Other Study ID Numbers: ShandongCHI005
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents