Carmustine in Treating Patients With Recurrent Malignant Glioma

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004028

Enrollment

Unknown

Registered

2003-01-27

Start date

1996-09-30

Completion date

Unknown

Last updated

2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGcarmustine

PROCEDUREconventional surgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026