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New treatment option for Glioblastoma, Recurrent
Official title Study of Recombinant Human Endostatin Combined with Temozolomide and Irinotecan in Recurrent Gliomas
ClinicalTrials.gov ID: NCT04267978
What this study is testing
What is recombinant human endostatin,temozolomide,irinotecan?
recombinant human endostatin,temozolomide,irinotecan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma, recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Almost all gliomas relapse. After temozolomide rechallenge or combination with irinotecan, the progression-free survival rate at 6 months (PFS-6%) of recurrent glioblastoma was about 21%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age ≥ 18 and ≤70;
- Histopathologically-confirmed, supratentorial GBM or lower-grade gliomas (such as oligodendroglioma, astrocytoma, oligoastrocytoma, anaplastic...
- Recurrence is pathologically confirmed by another biopsy or surgery, which should have been completed at least 2 weeks before enrollment, or...
- Received standard chemoradiotherapy and at least one cycle of chemotherapy after primary diagnosis;
- The time intervals between the last radiotherapy and enrollment are at least 3 months;
You likely can't join if
- MRI examination is not available (such as pacemaker, metal denture);
- Receiving any other investigational agent.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in this study.
- Patients who have received organ transplants.
- Patients with HIV or Treponema pallidum infection.
- Severe heart disease; ECG shows T wave inversion or elevation or ST segment specific changes.
See the full eligibility criteria
- Age ≥ 18 and ≤70;
- Histopathologically-confirmed, supratentorial GBM or lower-grade gliomas (such as oligodendroglioma, astrocytoma, oligoastrocytoma, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma);
- Recurrence is pathologically confirmed by another biopsy or surgery, which should have been completed at least 2 weeks before enrollment, or confirmed by the MRI according to RANO criteria, at least one bi-dimensionally...
- Received standard chemoradiotherapy and at least one cycle of chemotherapy after primary diagnosis;
- The time intervals between the last radiotherapy and enrollment are at least 3 months;
- The interval form the last chemotherapy to the study enrollment was at least one interval of chemotherapy with recover from the related toxic effects (except for hair loss and pigmentation);
- Karnofsky Performance Status ≥ 60;
- If the patient is on glucocorticoid therapy, hormone dosage should be stable or decreased at least 5 days before baseline MRI;
- If the patient is receiving enzyme-inducing antiepileptic drugs (EIAEDs), the drugs should be replaced with non-EIAEDs for at least 1 weeks away from enrollment;
- Estimated survival of at least 12 weeks;
- Participants must have adequate organ function as defined by the following criteria (within 7 days before treatment):
- Hematology (No transfusion within 14 days):
- Hemoglobin(HB)≥90g/L;
- Absolute neutrophil count (ANC)≥1.5×109/L;
- Platelet (PLT)≥80×109/L.
- Chemistry:
- Serum bilirubin ≤ 1.5×upper limit of normal (ULN)
- ALT and AST≤2.5ULN；
- Serum creatinine ≤1.5ULN or creatinine clearance rate(CCr)≥60ml/min；
- ECG: heart rate in the normal range (55-100beats/min), normal or slightly prolonged QT interval (QTc\<480ms), normal or low T wave, normal or non-specific ST segment changes.
- Both men and women at the gestational age must agree to take adequate contraceptive measures throughout the study period.
- Participants volunteered to participate in the study and signed an informed consent form (ICF)
- MRI examination is not available (such as pacemaker, metal denture);
- Receiving any other investigational agent.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in this study.
- Patients who have received organ transplants.
- Patients with HIV or Treponema pallidum infection.
- Severe heart disease; ECG shows T wave inversion or elevation or ST segment specific changes.
- Having factors that affect oral drug absorption, such as vomiting, diarrhea and intestinal obstruction
- There were clinically significant bleeding symptoms or clear bleeding tendency in the first 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation...
- Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and...
- Having bleeding disorder and are being treated with thrombolytic or anticoagulant drugs.
- Other conditions considered inappropriate by the researcher for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.