Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
temozolomide
Brain Diseases+23
+ Central Nervous System Diseases
+ Cranial Nerve Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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 MapsChildren's Hospital of Philadelphia
Philadelphia, United States