Clinical trial NCT00006263: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: 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
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 0
Sex: ALL
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonathan L. Finlay, MB, ChB
role: STUDY_CHAIR
References: