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
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 |
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.
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 |
Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Neurocrine Biosciences |
United States,
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