Temozolomide in Treating Patients With Progressive Low-Grade Glioma
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal |
- Response rate [ Designated as safety issue: No ]
- Activity of temozolomide [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 1998 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| Study Chair: | Henry S. Friedman, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00003466 History of Changes |
| Other Study ID Numbers: | 1703 (CDR0000066502), DUMC-1703-04-12R7, DUMC-000693-01-3R1, DUMC-1703-01-94R, DUMC-1502-97-10, DUMC-1569-98-10R1, DUMC-97125, NCI-G98-1469, DUMC-1703-02-9R5 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Duke University:
|
recurrent adult brain tumor adult mixed glioma childhood mixed glioma adult pilocytic astrocytoma adult subependymoma recurrent childhood cerebral astrocytoma adult brain stem glioma |
recurrent childhood brain stem glioma untreated childhood brain stem glioma recurrent childhood visual pathway and hypothalamic glioma untreated childhood visual pathway and hypothalamic glioma adult oligodendroglioma adult diffuse astrocytoma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013