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Carmustine in Treating Patients With Recurrent Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004028
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 10, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 9, 2009
Study Start Date  ICMJE September 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00004028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Carmustine in Treating Patients With Recurrent Malignant Glioma
Official Title  ICMJE PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
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.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: carmustine
  • Procedure: conventional surgery
Study Arms Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004028
Other Study ID Numbers  ICMJE CDR0000065129
NABTT-101-9601
JHOC-NABTT-101-9601
NCI-T96-0052H
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Alessandro Olivi, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account National Cancer Institute (NCI)
Verification Date January 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP