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


Phase 2
N/A
64 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jonathan L. Finlay, MB, ChB

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000068203

NCT ID:

NCT00006263

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult brain stem glioma
  • adult glioblastoma
  • childhood high-grade cerebral astrocytoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016