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Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00006263
First received: September 11, 2000
Last updated: January 14, 2011
Last verified: January 2011

September 11, 2000
January 14, 2011
November 1997
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Complete list of historical versions of study NCT00006263 on ClinicalTrials.gov Archive Site
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Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.

OBJECTIVES:

  • Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide, carboplatin, and filgrastim (G-CSF).
  • Determine the toxicity of this treatment regimen in these patients.
  • Determine the rate of tumor progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to disease category (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas).

Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this study within 4 years.

Interventional
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: temozolomide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma

    • Residual tumor on postoperative MRI
  • Bidimensionally measurable disease

PATIENT CHARACTERISTICS:

Age:

  • Under 65

Performance status:

  • Karnofsky or Lansky 70-100% OR
  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Hemoglobin at least 8 g/dL (transfusion allowed)
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGPT no greater than 3 times ULN

Renal:

  • Age 5 years and under: Creatinine less than 1.2 mg/dL
  • Age over 5 to 10 years: Creatinine less than 1.5 mg/dL
  • Age over 10 to 15 years: Creatinine less than 1.8 mg/dL
  • Age over 15 years: Creatinine less than 2.4 mg/dL

Cardiovascular:

  • No myocardial infarction within the past 6 months

Other:

  • No other concurrent serious medical condition that would preclude study
  • Able to tolerate oral medications
  • No prior malignancy for which patient received prior chemotherapy or spinal irradiation
  • No history of severe allergic reaction to platinum-containing compounds
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 72 hours since prior filgrastim (G-CSF)

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids for tumor-related cerebral edema allowed
  • No concurrent corticosteroids for solely antiemetic purposes

Radiotherapy:

  • No prior or concurrent radiotherapy

Surgery:

  • Recovered from prior surgery
  • No concurrent surgery
Both
up to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006263
CDR0000068203, NYU-0004H, NYU-0029H, NCI-G00-1856
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New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Jonathan L. Finlay, MB, ChB New York University School of Medicine
New York University School of Medicine
January 2011

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