Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Recruitment status was Active, not recruiting
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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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas |
| Study Start Date: | July 2002 |
OBJECTIVES:
- Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
- Determine the toxicity of this regimen in these patients.
- Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response [PR] vs complete response [CR]).
Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.
Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.
Patients with CR after completion of neoadjuvant temozolomide undergo observation.
Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma
- Unifocal or multifocal disease
- Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy
- No equivocal oligodendroglial element
- No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
- No spinal cord tumors
- No evidence of spinal drop metastasis or spread to noncontiguous meninges
PATIENT CHARACTERISTICS:
Age:
- 18 to 65
Performance status:
- Zubrod 0-1
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 2 times normal
- AST no greater than 3 times normal
- Alkaline phosphatase no greater than 2 times normal
Renal:
- Creatinine no greater than 1.5 times normal
Other:
- No active infection
- No other medical problems that would preclude study participation
- No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy for this malignancy
- No prior temozolomide
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the brain, head, or neck
Surgery:
- At least 14 days since prior surgery requiring general anesthesia
Contacts and Locations
Show 39 Study Locations| Study Chair: | Michael A. Vogelbaum, MD, PhD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00033280 History of Changes |
| Other Study ID Numbers: | CDR0000069270, RTOG-BR-0131, RTOG-DEV-1080 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult anaplastic oligodendroglioma adult mixed glioma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Oligodendroglioma Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013