Clinical trial NCT00677716: Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
Official title: Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: glioblastoma multiforme
GBM
brain cancer
Cotara
radioactive isotope
monoclonal antibody
Glioblastoma multiforme at first relapse
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.

To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed GBM
* Clinical Target Volume between 5 and 60 cc (inclusive)
* 18 to 75 years old (inclusive)
* Karnofsky Performance Status ≥ 70 percent
* If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
* Adequate hematology
* Adequate renal function
* Adequate liver function

Exclusion Criteria:

* Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
* Bilateral non-contiguous gadolinium enhancing tumor
* Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
* Known or suspected allergy to study medication or iodine
* Surgical procedure within four weeks of baseline
* More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline
* Radiation therapy within four weeks of baseline
* Investigational agent within last 30 days
* Previous treatment with any chimeric monoclonal antibody
* HIV positive
* Evidence of active hepatitis

Primary outcomes:
measure: To confirm the safety and tolerability of the maximum tolerated dose
Secondary outcomes:
measure: To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Philadelphia
country: United States
facility: University of Pennsylvania, Department of Neurosurgery
state: Pennsylvania
city: Charleston,
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Cochin
country: India
facility: Amrita Institute of Medical Sciences and Research Center,
state: Kerala
city: Bangalore
country: India
facility: Manipal Institute for Neurological Disorders,
city: Mumbai
country: India
facility: Department of Neurosurgery Jaslok Hospital and Research Centre
city: New Delhi
country: India
facility: All India Instutite of Medical Sciences
Study officials:
affiliation: All India Institute of Medical Sciences
name: Deepak K Gupta, MBBS,MS,MCh
role: PRINCIPAL_INVESTIGATOR
References: