Glioblastoma Multiforme Clinical Trial
— Glass-ArtOfficial title:
A Phase III Randomized Study of Neuradiab in Combination With External Beam Radiation and Temozolomide Versus External Beam Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
The current study will investigate whether the addition of Neuradiab to surgery, radiation and adjuvant chemotherapy (temozolomide) will improve the survival of patients with glioblastoma and whether the drug regimen is safe.
Status | Terminated |
Enrollment | 9 |
Est. completion date | December 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Newly diagnosed supratentorial unifocal lesion seen on magnetic resonance imaging (MRI). - Patient must have undergone a gross total surgical resection of the tumor mass with post surgical MRI (performed within 14 days of randomization) demonstration of adequacy defined as < 1.0 cm of residual enhancement away from resection cavity perimeter. - Histopathologically confirmed diagnosis of glioblastoma (World Health Organization [WHO] grade IV astrocytoma) and tumor sample is available. (http://rad.usuhs.mil/rad/who/who2b.html) - Age = 18 years of age at the time of study entry. - Karnofsky Performance Status = 60%. - Adequate bone marrow function, defined as: 1. Absolute neutrophil count = 1500 cells/mm3 2. Hemoglobin = 10 g/dL 3. Platelet count = 100,000 cells/mm3 - Adequate hepatic function, defined as: 1. Bilirubin = 1.5 mg/dL 2. SGOT = 2.5 × upper limit of normal (ULN - Adequate renal function, defined as creatinine = 1.3 mg/dL (µmol/L) - Patients must have a negative HAMA (human anti-murine antibody) assay. - Women of childbearing potential must have a negative pregnancy test (serum or urine). - Men and women of reproductive potential must agree to use an effective contraceptive method including one of the following: surgical sterilization (tubal ligation for women or vasectomy for men); approved hormonal contraceptives (such as birth control pills, Depo-Provera or Lupron Depro); barrier methods (such as condom or diaphragm) used with a spermicide cream or an intrauterine device (IUD). - Patient must give written informed consent prior to any study-specific procedures being implemented. Exclusion Criteria: - Infratentorial tumor, tumor with subependymal spread, multifocal tumor, tumor with ventricular communication, intraventricular tumor or tumor which abuts the motor strip or exceeds beyond the cranial vault. - Pregnant or lactating females. - Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. - No severe, active comorbidity, including any of the following: 1. Unstable angina and/or congestive heart failure requiring hospitalization 2. Transmural myocardial infarction within the last 6 months 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of randomization 5. Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects 6. Known AIDS based upon current CDC definition 7. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy 8. Active connective tissue disorders, such as lupus or scleroderma that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity. - Prior or planned chemotherapy, immunotherapy, biologic therapy, radiation therapy, radioimmunotherapy, hormonal therapy, or experimental therapy for brain tumor. Prior or active corticosteroid therapy is permitted. - History of severe allergic reaction to contrast media. - Any serious medical condition or psychiatric illness unresponsive to medical intervention. - Prior malignancy if active treatment was required during the previous 3 years except for adequately treated basal cell or squamous cell skin cancer and in situ uterine cervical cancer. - Known hypersensitivity to murine proteins. - Inability to undergo an MRI. - Patients treated on any other therapeutic clinical trial within 30 days prior to study entry or during participation in the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bradmer Pharmaceuticals Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary measure of efficacy is overall survival (OS). | Death from any cause | No | |
Secondary | Progression-free survival (PFS) is the sole secondary measure of efficacy. | Difference between the date of randomization and the first date of meeting objective criteria for disease progression or death, whichever event is earliest. | No |
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