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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Glioma, Brain Neoplasm

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Trial Information

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


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.

Inclusion Criteria


- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Diana M Hablitz, MSNCRNP

Investigator Role:

Study Director

Investigator Affiliation:

TransMolecular

Authority:

United States: Food and Drug Administration

Study ID:

TM601-001

NCT ID:

NCT00040573

Start Date:

June 2002

Completion Date:

August 2003

Related Keywords:

  • Glioma
  • Brain Neoplasm
  • Brain neoplasm
  • Clinical trial, phase I/II
  • Brain Neoplasms
  • Neoplasms
  • Glioma

Name

Location

City of HopeDuarte, California  91010
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Saint Louis UniversitySt. Louis, Missouri  63104