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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry Pan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Neurocrine Biosciences

Authority:

United States: Federal Government

Study ID:

CDR0000068586

NCT ID:

NCT00014677

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Emory University Hospital - AtlantaAtlanta, Georgia  30322
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Charlotte Neurosurgical AssociatesCharlotte, North Carolina  28207-1830
UCSD Thornton HospitalLa Jolla, California  92037