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Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
This study is ongoing, but not recruiting participants.
Study NCT00004204   Information provided by National Cancer Institute (NCI)
First Received: January 21, 2000   Last Updated: July 23, 2008   History of Changes

January 21, 2000
July 23, 2008
February 2000
 
 
 
Complete list of historical versions of study NCT00004204 on ClinicalTrials.gov Archive Site
 
 
 
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas

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 temozolomide in treating patients who have recurrent or progressive malignant glioma.

OBJECTIVES:

  • Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
  • Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).

Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
Drug: temozolomide
 
 

*   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 proven recurrent or progressive malignant glioma of one of the following types:

    • Anaplastic oligodendroglioma or oligoastrocytoma
    • Anaplastic astrocytoma
    • Glioblastoma multiforme (stratum closed to accrual 11/30/01)
  • Patients who have failed radiotherapy are eligible
  • Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL

Hepatic:

  • SGOT or SGPT less than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)

Renal:

  • BUN less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No other serious concurrent infection or other medical illness that would preclude study entry
  • No frequent vomiting or partial bowel obstruction
  • HIV negative
  • No AIDS-related illness
  • No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent epoetin alfa

Chemotherapy:

  • At least 6 weeks since other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)

Surgery:

  • Recovered from prior surgery

Other:

  • No other concurrent investigational agents
  • Concurrent anticonvulsant therapy allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004204
 
CDR0000067449, CPMC-IRB-8622, SPRI-CPMC-IRB-8622
Herbert Irving Comprehensive Cancer Center
 
Study Chair: Casilda Balmaceda, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2006

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