Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma |
- Progression-Free Survival [ Time Frame: Survival of Last Patient ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Post-Treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
-
Drug: temozolomide
OBJECTIVES:
- Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
- Determine the response rate in these patients.
- Assess the quality of life of patients with AO or MOA treated with this regimen.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:
- Bidimensionally measurable disease
- Evaluable disease
- Nonevaluable disease as demonstrated by gross total surgical resection
- No immediate need for cranial irradiation
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 12 weeks
- Absolute granulocyte count ≥ 1,500/mm³
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.0 times ULN
- AST ≤ 3.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No infection requiring systemic antibiotics within the past 14 days
- No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
- No unrelated medical problems that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for this malignancy
- No prior radiotherapy to the brain
- No surgery requiring general anesthesia > 2 hours in duration within the past 10 days
- No prior temozolomide
- Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry
Contacts and Locations| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | David M. Peereboom, MD | Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cleveland Clinic Foundation, David Peereboom, MD |
| ClinicalTrials.gov Identifier: | NCT00400816 History of Changes |
| Other Study ID Numbers: | CASE-CCF-4204, P30-CA43703 |
| Study First Received: | November 16, 2006 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Cleveland Clinic:
|
adult anaplastic oligodendroglioma adult mixed glioma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Oligodendroglioma Central Nervous System Neoplasms Astrocytoma 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 June 18, 2013