Clinical trial NCT00004028: Carmustine in Treating Patients With Recurrent Malignant Glioma
Official title: PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult ependymoblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.

Detailed description: OBJECTIVES:

* Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma.

OUTLINE: This is a dose escalation study.

All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity.

Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study.

Patients are followed 3, 6, and 12 months after implantation.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Pathologically confirmed recurrent malignant glioma for which surgery is indicated
* Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 8 weeks

Hematopoietic:

* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal

Renal:

* Creatinine less than 1.5 times normal
* BUN less than 2.5 times normal
* Protein no greater than 3 g/dL
* No gross hematuria

Other:

* No hypersensitivity to nitrosoureas
* Not pregnant
* Fertile patients must use effective contraception
* No concurrent life threatening disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy during first 8 weeks of study

Chemotherapy:

* At least 4 weeks since chemotherapy (6 weeks since nitrosoureas)
* No concurrent chemotherapy during first 8 weeks of study

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required
* No concurrent radiotherapy or brachytherapy during first 4 weeks of study

Surgery:

* Prior cytoreductive surgery for supratentorial brain tumor required
* Biopsy alone not sufficient

Other:

* No concurrent investigational therapy during first 8 weeks of study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Alessandro Olivi, MD
role: STUDY_CHAIR
References:
citation: Olivi A, Grossman SA, Tatter S, Barker F, Judy K, Olsen J, Bruce J, Hilt D, Fisher J, Piantadosi S; New Approaches to Brain Tumor Therapy CNS Consortium. Dose escalation of carmustine in surgically implanted polymers in patients with recurrent malignant glioma: a New Approaches to Brain Tumor Therapy CNS Consortium trial. J Clin Oncol. 2003 May 1;21(9):1845-9. doi: 10.1200/JCO.2003.09.041.