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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Glioma, Glioblastoma Multiforme, GBM, Anaplastic Astrocytoma, Oligo-Astrocytoma, Gliosarcoma

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Trial Information

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


This phase II trial was designed in two sequences. The first sequence, which is now
complete to accrual was an open-label, dose escalation, multi-dose study and treated 12
evaluable patients with high-grade glioma.

The second sequence is currently open and accruing eligible subjects with high-grade glioma.
The trial is an open-label, randomized study and will accrue a total of 54 evaluable
patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I
labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first
sequence of the trial. Patients will undergo debulking surgery and placement of a
ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients
who participated in the first sequence are not eligible to participate in the second
sequence of the study.

High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma,
oligoastrocytoma or gliosarcoma.

Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI)
assessments, at defined intervals, until 12 months after the first study dose.


Inclusion Criteria:



- Patient must have a histologically confirmed unilateral, supratentorial malignant
glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or
malignant oligoastrocytoma)

- Patient must have glioma progression or recurrence following radiotherapy that was no
less than 50 Gy (+/- chemotherapy; +/- surgery)

- Patient must be a candidate for resection of the recurrent tumor (surgical
requirements are detailed in the study protocol)

- Imaging must show recurrent, unilateral, supratentorial tumor(s)

- There is no diffuse leptomeningeal disease

- For patients with previous radiosurgery or enhanced radiotherapy, based on
neurosurgeon's judgment, the area of enhancement can be removed during the surgery

- Patient must have recovered from toxicity of prior therapy

- Patient must be > 18 years of age.

- Patient has a Karnofsky Performance Status greater than or equal to 60%

- Patient must have a life expectancy of at least 3 months

- Patient has no uncontrolled seizures or other neurological conditions which would
interfere with evaluation

- Patient is not currently receiving, or is not anticipated to receive, concomitant
anticancer agent(s) during the course of this study

- Patient must have given informed consent

Exclusion Criteria:

- Patient with concurrent malignancy (except curatively treated basal or squamous cell
carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with
prior malignancies that have not been disease-free for five years

- Patient has presence of non-contiguous satellite lesions

- Patient with known allergy to iodine, iodine containing drugs or contrast agent

- Patient with the potential for pregnancy or impregnating their partner and who do not
agree to follow an acceptable birth control method to avoid conception

- Pregnant or breast feeding females

- Patient is not maintained on a stable corticosteroid regimen

- New onset of conditions not present prior to surgery (as detailed in Study Protocol)
which would make patient an inappropriate study candidate, or as determined by
Investigator

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma

Outcome Time Frame:

28 days post last dose

Safety Issue:

Yes

Principal Investigator

John Fiveash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

TM-601-002

NCT ID:

NCT00114309

Start Date:

November 2004

Completion Date:

August 2009

Related Keywords:

  • Malignant Glioma
  • Glioblastoma Multiforme
  • GBM
  • Anaplastic Astrocytoma
  • Oligo-Astrocytoma
  • Gliosarcoma
  • High grade recurrent glioma
  • Phase II
  • Multi-Center
  • Open label
  • Multiple dose
  • Brain Cancer
  • Brain Tumor
  • GBM
  • glioma
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Gliosarcoma
  • Oligodendroglioma

Name

Location

Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Cedars-Sinai Medical CenterLos Angeles, California  90048
Florida Hospital Cancer InstituteOrlando, Florida  32804
Washington University Medical CenterSaint Louis, Missouri  63105
University of WashingtonSeattle, Washington  98195
City of HopeDuarte, California  91010
Mary Crowley Medical Research CenterDallas, Texas  75246
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Northwestern UniversityChicago, Illinois  60611
Emory UniversityAtlanta, Georgia  30322
University of ChicagoChicago, Illinois  60637
Moffitt Cancer CenterTampa, Florida  33612
Johns Hopkins Medical CenterBaltimore, Maryland  
Columbia University Medical CenterNew York, New York  10032
Tufts-New England Medical CenterBoston, Massachusetts  02111
Lacks Cancer Center at St. Mary's Health CareGrand Rapids, Michigan  49503
St. Louis HospitalSt. Louis, Missouri  63110
Carolina Neurosurgery and SpineCharlotte, North Carolina  28204