Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.

A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.

Sponsoren

Hauptsponsor: TransMolecular

Quelle TransMolecular
Kurze Zusammenfassung

This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

detaillierte Beschreibung

This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.

Gesamtstatus Completed
Anfangsdatum June 2002
Fertigstellungstermin August 2003
Phase Phase 1/Phase 2
Studientyp Interventional
Einschreibung 18
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: 131I-TM-601

Teilnahmeberechtigung

Kriterien:

- Patient must have given informed consent

- Patient must have histologically confirmed supratentorial malignant glioma

- Patients must have recovered from toxicity of prior therapy

- Patients must be eligble for resection of the recurrent tumor

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Diana M Hablitz, MSNCRNP Study Director TransMolecular
Ort
Einrichtung:
University of Alabama at Birmingham | Birmingham, Alabama, 35294-3295, United States
City of Hope | Duarte, California, 91010-3000, United States
Saint Louis University | St. Louis, Missouri, 63110-0250, United States
Standort Länder

United States

Überprüfungsdatum

March 2009

Schlüsselwörter
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov