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Bortezomib in Treating Patients With Recurrent Glioma
This study has been completed.
Study NCT00006773   Information provided by National Cancer Institute (NCI)
First Received: December 6, 2000   Last Updated: May 23, 2008   History of Changes

December 6, 2000
May 23, 2008
January 2001
 
 
 
Complete list of historical versions of study NCT00006773 on ClinicalTrials.gov Archive Site
 
 
 
Bortezomib in Treating Patients With Recurrent Glioma
Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma.

OBJECTIVES:

  • Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma.
  • Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients .
  • Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on biologic activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent anticonvulsant drug use (phenytoin, carbamazepine, phenobarbital, primidone, or felbamate vs gabapentin, lamotrigine, valproic acid, or no anticonvulsant drugs).

Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated with bortezomib at the MTD.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 14 months.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
Drug: bortezomib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
42
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed progressive or recurrent malignant glioma

    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Glioblastoma multiforme
  • Prior low-grade gliomas that have progressed to high-grade after therapy allowed
  • Measurable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 4 times upper limit of normal

Renal:

  • Creatinine no greater than 1.7 mg/dL

Other:

  • Mini mental score at least 15
  • No concurrent serious infection or other medical illness that would preclude study participation
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No more than 1 prior chemotherapy regimen

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 months since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No other concurrent investigational agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006773
 
CDR0000068326, NABTT-9910, JHOC-NABTT-9910
National Cancer Institute (NCI)
 
Study Chair: Jeffrey J. Olson, MD Emory University
National Cancer Institute (NCI)
November 2006

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