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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: filgrastim
Drug: carboplatin
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: November 1997
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.

  Eligibility

Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006263

Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Jonathan L. Finlay, MB, ChB New York University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006263     History of Changes
Other Study ID Numbers: CDR0000068203, NYU-0004H, NYU-0029H, NCI-G00-1856
Study First Received: September 11, 2000
Last Updated: January 14, 2011
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
adult brain stem glioma
adult glioblastoma
childhood high-grade cerebral astrocytoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Carboplatin
Lenograstim
Temozolomide
Adjuvants, Immunologic
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014