Expired Study
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New York, New York 10016


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000068203


NCT ID:

NCT00006263


Secondary ID:

NYU-0004H


Study Acronym:


Brief Title:

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


Official Title:

Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent


Overall Status:

Withdrawn


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

64 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jonathan L. Finlay, MB, ChB
Study Chair
New York University School of Medicine

Study Dates

Start Date:November 1997
Verification Date:August 2015
Last Changed Date:August 3, 2015
First Received Date:September 11, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:filgrastim
Intervention Type:Drug
Name:carboplatin
Intervention Type:Drug
Name:temozolomide

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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