Clinical trial · Interventional
Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors by Continuous Intravenous Pumping
NCT02104323CI-TRIAL-00025879EndostatincompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized double-blind trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 2 | — | UNRESOLVED | — |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostatin，treatment effect evaluation
- description
- Patients receive continuous intravenous Endostatin drug pumping during the course of treatment. The drug dosage is 7.5mg/m2/d. Every course of treatment lasts three months. Patients are designed to receive total three courses of treatment if there is no disease progression. The interval between two courses is one month.
- interventionNames
- Drug: Endostatin
Primary outcomes (1)
- measure
- Change from Baseline in volume of tumour after every course of the treatment
- timeFrame
- Baseline,Month 3,Month 7,Month 11
- description
- Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * 1)Patients must be at the age of 16-30 * 2)Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors * 3)Patients must not be treated with other drugs or radiation therapy recently * 4)Patients should live in Beijing or nearby and can be treated in hospital * 5)Patients must be healthy and not be seriously allergic with biological agents * 6)Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent. Exclusion Criteria: * 1)Treated with other drugs, surgery or radiation therapy recently * 2)Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time * 3)Being pregnant or try to get pregnant, lactating women * 4)With acute or chronic infectious diseases * 5)With heart diseases, cardiac dysfunction or abnormal ECG * 6)With uncontrolled neural or mental diseases, poor compliance * 7)Not available for enhanced MRI * 8)Take part in any other clinical trial * 9)With other conditions that are considered not suitable for this clinical trial.
References
Publications (5)
- BACKGROUNDPlotkin SR, Merker VL, Halpin C, Jennings D, McKenna MJ, Harris GJ, Barker FG 2nd. Bevacizumab for progressive vestibular schwannoma in neurofibromatosis type 2: a retrospective review of 31 patients. Otol Neurotol. 2012 Aug;33(6):1046-52. doi: 10.1097/MAO.0b013e31825e73f5. PMID 22805104
- BACKGROUNDPlotkin SR, Stemmer-Rachamimov AO, Barker FG 2nd, Halpin C, Padera TP, Tyrrell A, Sorensen AG, Jain RK, di Tomaso E. Hearing improvement after bevacizumab in patients with neurofibromatosis type 2. N Engl J Med. 2009 Jul 23;361(4):358-67. doi: 10.1056/NEJMoa0902579. Epub 2009 Jul 8. PMID 19587327
- BACKGROUNDNunes FP, Merker VL, Jennings D, Caruso PA, di Tomaso E, Muzikansky A, Barker FG 2nd, Stemmer-Rachamimov A, Plotkin SR. Bevacizumab treatment for meningiomas in NF2: a retrospective analysis of 15 patients. PLoS One. 2013;8(3):e59941. doi: 10.1371/journal.pone.0059941. Epub 2013 Mar 21. PMID 23555840
- BACKGROUNDPlotkin SR, Ardern-Holmes SL, Barker FG 2nd, Blakeley JO, Evans DG, Ferner RE, Hadlock TA, Halpin C; REiNS International Collaboration. Hearing and facial function outcomes for neurofibromatosis 2 clinical trials. Neurology. 2013 Nov 19;81(21 Suppl 1):S25-32. doi: 10.1212/01.wnl.0000435746.02780.f6. PMID 24249803
- BACKGROUNDMautner VF, Nguyen R, Kutta H, Fuensterer C, Bokemeyer C, Hagel C, Friedrich RE, Panse J. Bevacizumab induces regression of vestibular schwannomas in patients with neurofibromatosis type 2. Neuro Oncol. 2010 Jan;12(1):14-8. doi: 10.1093/neuonc/nop010. Epub 2009 Oct 20. PMID 20150363