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Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade 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.
 
ClinicalTrials.gov Identifier: NCT00006263
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : August 5, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE September 11, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date August 5, 2015
Study Start Date  ICMJE November 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00006263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Official Title  ICMJE Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: temozolomide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August¬†3,¬†2015)
0
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006263
Other Study ID Numbers  ICMJE CDR0000068203
NYU-0004H
NYU-0029H
NCI-G00-1856
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jonathan L. Finlay, MB, ChB NYU Langone Health
PRS Account NYU Langone Health
Verification Date August 2015

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