Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors Thrombocytopenia

Keywords

thrombocytopeniaadult anaplastic oligodendrogliomaadult brain stem gliomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcomaadult glioblastomaadult anaplastic astrocytomaadult anaplastic ependymomaadult 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

Interventions

temozolomideDrug

comparative genomic hybridizationGenetic

polymorphism analysisGenetic

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Otherlead

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsThrombocytopeniaOligodendrogliomaGliomaGlioblastomaGliosarcomaAstrocytomaEpendymoma

Interventions

TemozolomideComparative Genomic HybridizationAmplified Fragment Length Polymorphism AnalysisRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by Site

Study Officials

Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
STUDY CHAIR

Enrollment

10 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

Intervention Hierarchy (Ancestors)

Source record

Locations