Glioblastoma Multiforme
Conditions
Keywords
glioblastoma multiforme, GBM, brain cancer, Cotara, radioactive isotope, monoclonal antibody, Glioblastoma multiforme at first relapse
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.
Interventions
DRUG131I-chTNT-1/B MAb (Cotara)
Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm the safety and tolerability of the maximum tolerated dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment. | — |
Countries
India, United States
Outcome results
None listed