drugset / Trial / NCT02104323
Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Phase 2
Completed
20 enrolled
Beijing Tiantan Hospital
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-01
- Primary completion
- 2016-04
- Completion
- 2016-04
Publications
- Background Plotkin 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.
- Background Plotkin 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.
- Background Nunes 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.
- Background Plotkin 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.
- Background Mautner 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Endostar | Protein / enzyme biologic | 7.5 mg/m2 | Intravenous |