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Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

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. Identifier: NCT00006656
Recruitment Status : Unknown
Verified August 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine in ethanol Procedure: conventional surgery Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
  • Determine the qualitative and quantitative toxicity of this regimen in these patients.
  • Assess the activity of this regimen in these patients.
  • Estimate peripheral blood carmustine levels in these patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.

Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)

Additional patients then receive treatment with DTI-015 at the recommended phase II dose.

Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression.

PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
Study Start Date : June 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven supratentorial malignant glioblastoma multiforme

    • Clear evidence of disease progression by MRI
    • Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
    • Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
    • No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
    • No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
    • No tumor extension into the ventricular system
    • Tumor volume no greater than 33.4 cm3
  • At least one prior radiotherapy



  • 18 to 75

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No evidence of bleeding diathesis


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2.5 times normal


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 40 mL/min
  • BUN no greater than 30 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active uncontrolled infection
  • Afebrile unless fever due to presence of tumor
  • No other concurrent serious medical or psychiatric illness that would preclude study


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior intracranial brachytherapy


  • Recovered from any prior surgery


  • No prior anticoagulants
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006656

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United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9416
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
United States, New Jersey
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08820
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0631
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Direct Therapeutics
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Study Chair: Gene David Resnick, MD Millennix
Layout table for additonal information Identifier: NCT00006656    
Other Study ID Numbers: CDR0000068207
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: August 2003
Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents