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

NCT00006263 | Withdrawn Phase 2

• 4 other identifiers: CDR0000068203NYU-0004HNYU-0029HNCI-G00-1856
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

temozolomide DRUG

Eligibility Criteria

• Age: Up to 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Gliosarcoma

Interventions

Filgrastim; Carboplatin; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jonathan L. Finlay, MB, ChB

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: January 27, 2003
• Study Start: November 1, 1997
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

US (1)