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SarCNU in Treating Patients With Recurrent Malignant Glioma
This study is ongoing, but not recruiting participants.
Study NCT00036660   Information provided by National Cancer Institute (NCI)
First Received: May 13, 2002   Last Updated: July 23, 2008   History of Changes

May 13, 2002
July 23, 2008
August 2001
 
 
 
Complete list of historical versions of study NCT00036660 on ClinicalTrials.gov Archive Site
 
 
 
SarCNU in Treating Patients With Recurrent Malignant Glioma
A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma

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.

OBJECTIVES:

  • 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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
Drug: SarCNU
 
Webster M, Cairncross G, Gertler S, Perry J, Wainman N, Eisenhauer E. Phase II trial of SarCNU in malignant glioma: unexpected pulmonary toxicity with a novel nitrosourea: a phase II trial of the national cancer institute of canada clinical trials group. Invest New Drugs. 2005 Dec;23(6):591-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • 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)

Other:

  • At least 6 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No other concurrent anticancer treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00036660
 
CDR0000068652, CAN-NCIC-IND142
NCIC Clinical Trials Group
 
Study Chair: Lawrence C. Panasci, MD Jewish General Hospital
National Cancer Institute (NCI)
July 2002

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