Recurrent Glioblastoma Multiforme
Conditions
Keywords
brain cancer, Cotara, radioactive isotope, monoclonal antibody, radiation distribution
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.
Interventions
DRUG131-I-chTNT-1/B MAB
The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm dose limit and maximum tolerated dose and to characterize radiation distribution | — |
Countries
United States
Outcome results
None listed