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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interleukin-4 PE38KDEL cytotoxin
conventional surgery
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Thornton Hospital
  • Emory University Hospital - Atlanta
  • St. Louis University Health Sciences Center
  • Charlotte Neurosurgical Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
July 17, 2013
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00014677
Brief Title
NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurocrine Biosciences

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
interleukin-4 PE38KDEL cytotoxin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Pan, MD, PhD
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Charlotte Neurosurgical Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207-1830
Country
United States

12. IPD Sharing Statement

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

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