COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

SarCNU 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. Identifier: NCT00036660
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : March 27, 2020
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

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 sarCNU in treating patients who have recurrent malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: SarCNU Phase 2

Detailed Description:


  • Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the time to progression and survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
Actual Study Start Date : January 10, 2002
Actual Primary Completion Date : April 15, 2003
Actual Study Completion Date : September 22, 2008

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant glioma

    • Anaplastic astrocytoma (AA) OR
    • Glioblastoma multiforme (GBM)
  • Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy
  • At least 1 bidimensionally measurable lesion

    • At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 120,000/mm3


  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • DLCO at least 70% of predicted
  • FVC at least 70% of predicted


  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
  • No ongoing or active uncontrolled infection
  • No other serious illness or medical condition that would preclude study
  • No history of significant neurologic or psychiatric disorder that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study


Biologic therapy:

  • At least 6 weeks since prior immunotherapy
  • No concurrent immunotherapy


  • At least 6 weeks since prior chemotherapy
  • No more than 1 prior adjuvant chemotherapy regimen for AA
  • No prior chemotherapy for recurrent disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • Patients must be on a stable dose of steroids for at least 2 weeks prior to study


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy for recurrent disease
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed
  • At least 4 weeks since prior surgery (except for biopsy)


  • At least 6 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No other concurrent anticancer treatment

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): NCT00036660

Layout table for location information
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
Layout table for investigator information
Study Chair: Lawrence C. Panasci, MD Jewish General Hospital

Publications of Results:
Layout table for additonal information
Responsible Party: NCIC Clinical Trials Group Identifier: NCT00036660    
Other Study ID Numbers: I142
CDR0000068652 ( Other Identifier: PDQ )
First Posted: July 8, 2003    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
Layout table for 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
Antineoplastic Agents