- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014677
NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme
A Randomized, Dose-Ranging, Safety and Tolerability Study of NBI-3001 Administered by Continuous Intratumoral Infusion Followed by Surgical Resection in Patients With Recurrent Glioblastoma Multiforme
RATIONALE: NBI-3001 may be able to locate cancer cells and stop them from growing. This may be an effective treatment for glioblastoma multiforme.
PURPOSE: Randomized phase II trial to compare different regimens of NBI-3001 followed by surgery to remove the tumor in treating patients who have glioblastoma multiforme.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the safety, tolerability, and optimal clinical dose of interleukin-4(38-37)-PE38KDEL cytotoxin (NBI-3001) followed by surgical resection in patients with recurrent glioblastoma multiforme.
OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive interleukin-4(38-37)-PE38KDEL cytotoxin (NBI-3001) intratumorally as a continuous infusion over 4-5 days beginning within 12-36 hours after ventricular catheter placement. Patients then undergo surgical tumor resection approximately 3 weeks after drug infusion. Cohorts of 6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose is determined. Patients are followed within 1 week and then at 8, 16, and 26 weeks.
PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92037
- UCSD Thornton Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Missouri
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Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
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North Carolina
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Charlotte, North Carolina, United States, 28207-1830
- Charlotte Neurosurgical Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma multiforme Previously treated with cytoreductive surgery Unilateral, unifocal tumor with a volume of 5-80 mL Not eligible for further radiotherapy due to prior external beam radiotherapy No multifocal, brain stem, or infratentorial tumor or tumor invading midline No tumor with a clinically significant mass effect (greater than 5 mm midline shift) while on stable dose of corticosteroid No clinical symptoms attributed to uncontrolled increased intracranial pressure and/or edema of the brain
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No focal or generalized seizure(s) within 30 days prior to enrollment No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No medical instability due to non-malignant systemic disease No other prior or concurrent condition that would preclude study compliance Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior antineoplastic chemotherapy Endocrine therapy: See Disease Characteristics Stable dose of dexamethasone for at least 72 hours prior to catheter placement Radiotherapy: See Disease Characteristics No prior radiosurgery boost (e.g., gamma knife or stereotactic radiosurgery) At least 8 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior craniotomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Henry Pan, MD, PhD, Neurocrine Biosciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interleukin-4
Other Study ID Numbers
- NBI-3001-0001
- CDR0000068586 (Registry Identifier: PDQ (Physician Data Query))
- NBI-BB-IND-7004
- SLUMC-11350
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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