Clinical trial NCT00509301: Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme
Official title: Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Glioblastoma Multiforme
Keywords: brain cancer
Cotara
radioactive isotope
monoclonal antibody
radiation distribution
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.

PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To confirm dose limit and maximum tolerated dose and to characterize radiation distribution
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sunil J Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Kenneth M Spicer, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Kevin D Judy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barrow Neurological Institute
name: William R Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Andrew E Sloan, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: