Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy

NCT00471653 | Terminated

• 4 other identifiers: J0684P30CA006973CDR0000543866NA_00004964
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients receiving temozolomide may help doctors learn how temozolomide works in the body. It may also help doctors learn more about how a patient's genes may affect the risk of developing thrombocytopenia. PURPOSE: This clinical trial is studying the pharmacokinetics in patients with newly diagnosed high-grade glioma receiving temozolomide and radiation therapy.

Conditions

Brain and Central Nervous System Tumors; Thrombocytopenia

Keywords

thrombocytopenia; adult anaplastic oligodendroglioma; adult brain stem glioma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic ependymoma; adult pineal gland astrocytoma

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics (PK) of temozolomide (TMZ) in patients with severe thrombocytopenia after standard first-line therapy as measured by Area Under the Curve (AUC)

  AUC (mg\*h/L)in patients who develop severe thrombocytopenia after receiving standard first-line therapy of temozolomide (TMZ) for management of newly diagnosed high-grade gliomas.

  Day 1, Day 22, Day 43

• Pharmacokinetics (PK) of temozolomide (TMZ) in patients with severe thrombocytopenia after standard first-line therapy as measured by maximum drug concentration (Cmax)

  Cmax in patients who develop severe thrombocytopenia after receiving standard first-line therapy of temozolomide (TMZ) for management of newly diagnosed high-grade gliomas.

  Day 1, Day 22, Day 43

• Pharmacokinetic (PK) profile of temozolomide (TMZ) in patients without severe thrombocytopenia after standard first-line therapy as measured by AUC

  AUC in patients in patients who do not develop severe thrombocytopenia after receiving standard first-line therapy of TMZ for management of newly diagnosed high-grade gliomas.

  Day 1, Day 22, Day 43

• Pharmacokinetic (PK) profile of temozolomide (TMZ) in patients without severe thrombocytopenia after standard first-line therapy as measured by Cmax

  Cmax in patients in patients who do not develop severe thrombocytopenia after receiving standard first-line therapy of TMZ for management of newly diagnosed high-grade gliomas.

  Day 1, Day 22, Day 43

Secondary Outcomes (1)

• Presence of single nucleotide polymorphisms in the O6-methylguanine-DNA methyltransferase gene.

  Day 1

Interventions

temozolomide DRUG

comparative genomic hybridization GENETIC

polymorphism analysis GENETIC

laboratory biomarker analysis OTHER

pharmacological study OTHER

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High grade glioma

DISEASE CHARACTERISTICS: * Histologically confirmed high-grade glioma (WHO grade III or IV) * Must be scheduled to receive standard first-line therapy (cranial radiotherapy and temozolomide) PATIENT CHARACTERISTICS: * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.7 mg/dL * Bilirubin ≤ 1.5 mg/dL * Transaminases ≤ 4 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell carcinoma of the skin PRIOR CONCURRENT THERAPY: * No prior hormonal therapy for brain tumor * No prior biological agents (including immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy) * No prior immunotherapy * No prior chemotherapy * No prior radiotherapy, including cranial radiotherapy * Concurrent glucocorticoid therapy allowed * No concurrent carbamazepine * No other concurrent experimental therapy * No other concurrent cytotoxic therapy

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Thrombocytopenia; Oligodendroglioma; Glioma; Glioblastoma; Gliosarcoma; Astrocytoma; Ependymoma

Interventions

Temozolomide; Comparative Genomic Hybridization; Amplified Fragment Length Polymorphism Analysis; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Therapeutics

Study Officials

• Stuart A. Grossman, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: November 11, 2006
• Primary Completion: November 12, 2008
• Study Completion: August 18, 2009
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

US (2)