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Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme


Phase 1
18 Years
N/A
Not Enrolling
Both
Recurrent Glioblastoma Multiforme

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Trial Information

Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme


OBJECTIVES:

Primary

- To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of
131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in
patients with recurrent GBM

- To characterize the biodistribution and radiation dosimetry of Cotara®

OUTLINE:

This is an open-label, dose escalation study of Cotara®.

All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry
purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara®
for confirmation of the maximum tolerated dose (MTD). After completion of study treatment,
patients are followed for a minimum of 12 weeks and until disease progression.


Inclusion Criteria:



- Patients with recurrent GBM

- Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)

- Patients of 18 years of age or older

- Karnofsky Performance Status ≥ 60 at screening

- Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg)
for at least 2 weeks prior to study entry

Exclusion Criteria:

- Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or
subependymal tumor spread extending greater than 2 cm

- Patients with diffuse disease

- Patients with known or suspected allergy to study medication or iodine

- Patients who received investigational agents within 30 days prior to baseline

- Patients who received surgical resection within 4 weeks from baseline

- Patients with known HIV or evidence of active hepatitis

- Patients who cannot undergo MRI

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To confirm dose limit and maximum tolerated dose and to characterize radiation distribution

Outcome Time Frame:

unknown

Safety Issue:

Yes

Principal Investigator

Sunil J Patel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Food and Drug Administration

Study ID:

PPHM 0602

NCT ID:

NCT00509301

Start Date:

November 2006

Completion Date:

March 2010

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • brain cancer
  • Cotara
  • radioactive isotope
  • monoclonal antibody
  • radiation distribution
  • Glioblastoma

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Barrow Neurological InstitutePhoenix, Arizona  85013
University Hospitals Case Medical CenterCleveland, Ohio  44106