NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014677
• Other study ID #: NBI-3001-0001
• Secondary ID: CDR0000068586NBI
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2001
• Last updated: July 17, 2013
• Start date: March 2001
• Est. completion date: July 2008

Study information

• Verified date: June 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2008
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Biological:
• interleukin-4 PE38KDEL cytotoxin

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Charlotte Neurosurgical Associates	Charlotte	North Carolina
United States	UCSD Thornton Hospital	La Jolla	California
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States,