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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00006263
• Other study ID #: CDR0000068203
• Secondary ID: NYU-0004HNYU-002
• Status: Withdrawn
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: August 3, 2015
• Start date: November 1997

Study information

• Verified date: August 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 64 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• carboplatin

• temozolomide

Locations

Country	Name	City	State
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,