Carmustine in Treating Patients With Recurrent Malignant Glioma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004028
First received: December 10, 1999
Last updated: February 6, 2009
Last verified: January 1999
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Procedure: conventional surgery
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1996
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004028

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3295
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Sponsors and Collaborators
Investigators
Study Chair: Alessandro Olivi, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004028     History of Changes
Other Study ID Numbers: CDR0000065129, NABTT-101-9601, JHOC-NABTT-101-9601, NCI-T96-0052H
Study First Received: December 10, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Carmustine
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014