Completed

Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

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What is being tested

temozolomide

Drug
Who is being recruted

Brain Diseases+23

+ Central Nervous System Diseases

+ Cranial Nerve Diseases

Over 4 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1998
See protocol details

Summary

Principal SponsorDuke University
Last updated: July 9, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide. Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients. OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma). Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.

NCT00003466
Principal SponsorDuke University
Last updated: July 9, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 4 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesCranial Nerve DiseasesCranial Nerve NeoplasmsEpendymomaEye DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsOptic Nerve DiseasesPeripheral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialOptic Nerve NeoplasmsAstrocytomaBrain NeoplasmsGliomaOligodendrogliomaCentral Nervous System NeoplasmsGlioma, SubependymalOptic Nerve Glioma

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: Astrocytoma Oligodendroglioma Mixed glioma Optic pathway glioma* Pontine glioma* NOTE: *Biopsy not required Patients with optic pathway glioma must also meet the following criteria: Progressive loss of vision as defined by doubling of octaves Visual acuity loss not explained by other causes Increase in proptosis of greater than 3 mm Increase in diameter of optic nerve of at least 2 mm on neuroimaging Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: 4 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring IV antibiotics No frequent vomiting No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) No other prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: At least 6 weeks since prior chemotherapy unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery unless evidence of disease progression Recovered from all prior surgery Other: No other concurrent investigational drugs

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Duke Comprehensive Cancer Center

Durham, United StatesOpen Duke Comprehensive Cancer Center in Google Maps

Children's Hospital of Philadelphia

Philadelphia, United States
Completed2 Study Centers