Glioblastoma Multiforme (GBM) Locoregional Agent Survival Study - Anti-tenascin Radiolabeled Antibody Therapy

NCT00615186 | Terminated Phase 3 DMC

• 1 other identifier: BRAD-301
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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 the drug regimen is safe.

Conditions

Glioblastoma Multiforme

Keywords

Neuradiab; Locoregional glioblastoma multiforme disease; Anti-tenascin; Radiolabeled antibody therapy; Survival

Outcome Measures

Primary Outcomes (1)

• The primary measure of efficacy is overall survival (OS).

  Death from any cause

Secondary Outcomes (1)

• 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.

Study Arms (2)

A

EXPERIMENTAL

Prior Surgery Rickham Catheter placement 99mTc-DTPA Flow Study Neuradiab Dosimetry Study Neuradiab Therapeutic Dose Administration Radiation Therapy (XRT) + Temozolomide: XRT 5 days/week + temozolomide (75 mg/m2/day) over 6.5 weeks. Post-Radiation Temozolomide Therapy: Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.

Drug: Neuradiab + Radiotherapy + Temozolomide

B

ACTIVE COMPARATOR

Prior Surgery: Gross total resection (\< 1 cm. enhancing rim) Radiation Therapy (XRT) + Temozolomide: XRT 5 days/week + 42 days of temozolomide (75 mg/m2/day) over 6.5 weeks Post-Radiation Temozolomide Therapy: Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.

Drug: Radiation Therapy + Temozolomide

Interventions

Neuradiab + Radiotherapy + Temozolomide DRUG

Prior Surgery Rickham Catheter placement 99mTc-DTPA Flow Study Neuradiab Dosimetry Study Neuradiab Therapeutic Dose Administration Radiation Therapy (XRT) + Temozolomide: XRT 5 days/week + temozolomide (75 mg/m2/day) over 6.5 weeks. Post-Radiation Temozolomide Therapy: Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.

A

Radiation Therapy + Temozolomide DRUG

Prior Surgery: Gross total resection (\< 1 cm. enhancing rim) Radiation Therapy (XRT) + Temozolomide: XRT 5 days/week + 42 days of temozolomide (75 mg/m2/day) over 6.5 weeks Post-Radiation Temozolomide Therapy: Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.

Also known as: Temodar (US)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bradmer Pharmaceuticals Inc.: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David A. Reardon, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Philip J Bierman, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Ray M. Chu, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Susan C. Pannullo, MD

  New York Presbyterian - Cornell

  PRINCIPAL INVESTIGATOR

• Frank D. Vrionis, MD, MPH, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 10, 2011

Record last verified: 2011-02