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Temozolomide in Treating Patients With Brain Metastases
This study has been completed.
Study NCT00005954   Information provided by Duke University
First Received: July 5, 2000   Last Updated: October 12, 2009   History of Changes

July 5, 2000
October 12, 2009
August 2000
 
 
 
Complete list of historical versions of study NCT00005954 on ClinicalTrials.gov Archive Site
 
 
 
Temozolomide in Treating Patients With Brain Metastases
Phase II Treatment of Adults With Brain Metastases With Temodar

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 brain metastases.

OBJECTIVES:

  • Determine the activity of temozolomide in patients with brain metastases.
  • Determine the toxicity of this treatment in these patients.

OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).

Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.

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.
 
Completed
 
June 2003
 

DISEASE CHARACTERISTICS:

  • Metastatic lesions to the brain

    • Must not require immediate radiotherapy
    • If received prior radiotherapy, must have progressive disease
  • Evaluable disease by CT scan or MRI
  • Neurologically stable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

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

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN

Renal:

  • Blood urea nitrogen 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 contraception
  • No other concurrent nonmalignant systemic disease
  • No acute infection requiring treatment with IV antibiotics
  • HIV negative
  • No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent hematopoietic growth factors, including epoetin alfa
  • No other concurrent biologic therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy, unless evidence of disease progression
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered

Other:

  • No other concurrent investigational drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005954
Henry Friedman, MD, Duke UMC
CDR0000067934, DUMC-2114-02-12R3, NCI-G00-1798
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke University
Duke University
October 2009

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