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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00114309
Other study ID # TM-601-002
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received June 13, 2005
Last updated April 1, 2009
Start date November 2004
Est. completion date August 2009

Study information

Verified date April 2009
Source TransMolecular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
131-I-TM-601
131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
131I-TM601
131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.

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Sponsors (1)

Lead Sponsor Collaborator
TransMolecular

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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-60 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma 28 days post last dose Yes
Primary Determine the toxicity of a three (3) and six (6) dose cycle of 131-I-TM-601 administrations into the tumor resection site of patients with recurrent high-grade glioma 28 days post last dose and then at 3 month intervals from first dose, until disease progression Yes
Primary Evaluate the 6 and 12-month rate of progression and survival of patients with recurrent high-grade glioma treated with a three (3) or six (6) dose cycle of 131-I-TM-601 at 3 month intervals from first dose administration, until disease progression No
Primary Evaluate the overall time to progression and death of patients with recurrent high-grade glioma treated with either a three (3) or six (6) dose cycle of 131-I-TM-601 at 3 month intervals until disease progression No
Secondary Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life 3 month intervals until disease progression No
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