drugset / Trial / NCT00591058
Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in adult patients with recurrent malignant glioma.
Timeline
- Start
- 2008-02
- Primary completion
- 2010-02
- Completion
- 2010-02
Publications
- Background Mamelak AN, Jacoby DB. Targeted delivery of antitumoral therapy to glioma and other malignancies with synthetic chlorotoxin (TM-601). Expert Opin Drug Deliv. 2007 Mar;4(2):175-86. doi: 10.1517/17425247.4.2.175.
- Background Mamelak AN, Rosenfeld S, Bucholz R, Raubitschek A, Nabors LB, Fiveash JB, Shen S, Khazaeli MB, Colcher D, Liu A, Osman M, Guthrie B, Schade-Bijur S, Hablitz DM, Alvarez VL, Gonda MA. Phase I single-dose study of intracavitary-administered iodine-131-TM-601 in adults with recurrent high-grade glioma. J Clin Oncol. 2006 Aug 1;24(22):3644-50. doi: 10.1200/JCO.2005.05.4569.
- Background Hockaday DC, Shen S, Fiveash J, Raubitschek A, Colcher D, Liu A, Alvarez V, Mamelak AN. Imaging glioma extent with 131I-TM-601. J Nucl Med. 2005 Apr;46(4):580-6.
- Background Lyons SA, O'Neal J, Sontheimer H. Chlorotoxin, a scorpion-derived peptide, specifically binds to gliomas and tumors of neuroectodermal origin. Glia. 2002 Aug;39(2):162-73. doi: 10.1002/glia.10083.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TM-601 | Unknown | 0.04 mg/kg | Intravenous |
| Subject | TM-601 | Unknown | 0.08 mg/kg | Intravenous |
| Subject | TM-601 | Unknown | 0.16 mg/kg | Intravenous |
| Subject | TM-601 | Unknown | 0.3 mg/kg | Intravenous |
| Subject | TM-601 | Unknown | 0.6 mg/kg | Intravenous |
| Subject | TM-601 | Unknown | 1.2 mg/kg | Intravenous |