Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Alessandro Olivi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065129

NCT ID:

NCT00004028

Start Date:

September 1996

Completion Date:

Related Keywords:

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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Henry Ford HospitalDetroit, Michigan  48202
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410