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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 64 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00006263
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jonathan L. Finlay, MB, ChB
Principal Investigator Affiliation NYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.#46;anaplastic astrocytoma vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Address

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016

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