Status:
TERMINATED
Glioblastoma Multiforme (GBM) Locoregional Agent Survival Study - Anti-tenascin Radiolabeled Antibody Therapy
Lead Sponsor:
Bradmer Pharmaceuticals Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
In all cases where surgery is a possibility, tumor removal is usually indicated as the first step of therapy for glioblastomas. The goals of such surgery include removal of as much tumor mass as possi...
Eligibility Criteria
Inclusion
- 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:
- Absolute neutrophil count ≥ 1500 cells/mm3
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000 cells/mm3
- Adequate hepatic function, defined as:
- Bilirubin ≤ 1.5 mg/dL
- 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
- 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:
- Unstable angina and/or congestive heart failure requiring hospitalization
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of randomization
- Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Known AIDS based upon current CDC definition
- Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00615186
Start Date
June 1 2008
End Date
December 1 2013
Last Update
February 10 2011
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