Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    50
  • sponsor
    Shandong Cancer Hospital and Institute
Updated on 23 January 2021
corticosteroids
measurable disease
karnofsky performance status
neutrophil count
glioblastoma multiforme
tumor progression

Summary

Anlotinib is a novel small molecule multi-target tyrosine kinase inhibitor that can inhibit tumor angiogenesis and inhibit tumor cell growth. We performed second-generation gene sequencing on pathological specimens and cerebrospinal fluid of patients with recurrent glioblastoma.If patients have a genetic mutation VEGFRKitPDGFRFGFRand meet other eligibility criteria, they will be treated with antroinib. The initial observation targets were progression-free survival and adverse reactions. The secondary objective was overal survival.

Description

INCLUSION CRITERIA:

  1. Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma.;
  2. Radiographic evidence of tumour progression or recurrence;
  3. The second-generation gene sequencing on pathological specimens and cerebrospinal fluid show at least one genetic mutation of the four genes (VEGFRKitPDGFRFGFR);
  4. 18 years of age;
  5. Karnofsky performance status (KPS) 70;
  6. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan.
  7. a new baseline scan is required 1.7 Measurable disease as per Response Assessment in Neuro-Oncology (RANO) criteria;
  8. Estimated survival of at least 3 months;
  9. signed informed consent form;
  10. Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/l; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;

EXCLUSION CRITERIA:

Exclusion Criteria:

  1. Subjects with newly diagnosed GBM
  2. Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions;
  3. Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3
  4. Severe or chronic renal insufficiency (creatinine clearance 30 ml/min);
  5. Patient unable to follow procedures, visits, examinations described in the study;
  6. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

Details
Condition Recurrent Glioblastoma
Treatment Anlotinib
Clinical Study IdentifierNCT04004975
SponsorShandong Cancer Hospital and Institute
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Recurrent Glioblastoma?
Do you have any of these conditions: Do you have Recurrent Glioblastoma??
Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma
Radiographic evidence of tumour progression or recurrence
The second-generation gene sequencing on pathological specimens and cerebrospinal fluid show at least one genetic mutation of the four genes (VEGFRKitPDGFRFGFR)
18 years of age
Karnofsky performance status (KPS) 70
Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan
a new baseline scan is required 1.7 Measurable disease as per Response Assessment in Neuro-Oncology (RANO) criteria
Estimated survival of at least 3 months
signed informed consent form
Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/l; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value

Exclusion Criteria

Subjects with newly diagnosed GBM
Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions
Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3
Severe or chronic renal insufficiency (creatinine clearance 30 ml/min)
Patient unable to follow procedures, visits, examinations described in the study
Any usual formal indication against imaging examinations (important claustrophobia, pacemaker)
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