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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
temozolomide
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult brain stem glioma, adult glioblastoma, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

undefined - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
August 3, 2015
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006263
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Study Start Date
November 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult brain stem glioma, adult glioblastoma, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
All
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan L. Finlay, MB, ChB
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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