Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 6, 2000
Last updated: November 5, 2013
Last verified: August 2003

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine in ethanol
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:

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

Study Start Date: June 2000
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.)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  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 identifier: NCT00006656

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
Study Chair: Gene David Resnick, MD Millennix
  More Information Identifier: NCT00006656     History of Changes
Other Study ID Numbers: CDR0000068207
Study First Received: December 6, 2000
Last Updated: November 5, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
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 processed this record on April 21, 2017