Carmustine in Treating Patients With Recurrent Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004028
• Other study ID #: CDR0000065129
• Secondary ID: NABTT-101-9601JH
• Status: Completed
• Phase: Phase 1
• First received: December 10, 1999
• Last updated: February 6, 2009
• Start date: September 1996

Study information

• Verified date: January 1999
• 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: 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• carmustine

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 g — View Citation