Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
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ClinicalTrials.gov Identifier: NCT00003465 |
Recruitment Status
:
Completed
First Posted
: March 12, 2004
Last Update Posted
: June 20, 2013
|
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with anaplastic oligodendroglioma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors | Drug: temozolomide | Phase 2 |
OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed, progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this drug in this patient population.
OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with progressive or recurrent disease (at baseline) continue treatment in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive an additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study treatment.) Patients are followed every 8 weeks for 2 years.
PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Primary Purpose: | Treatment |
Official Title: | Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal |
Study Start Date : | March 1998 |
Actual Study Completion Date : | February 2001 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least 1.5 cm2 by MRI
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Neurologically stable No nonmalignant systemic disease No acute infection treated with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy: No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No other concurrent investigational drugs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003465
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Henry S. Friedman, MD | Duke University |
Responsible Party: | Henry Friedman, MD, Duke UMC |
ClinicalTrials.gov Identifier: | NCT00003465 History of Changes |
Other Study ID Numbers: |
1534 DUMC-1534-00-8R3 DUMC-1372-97-9 DUMC-1403-98-9R1 DUMC-1550-99-9R2 DUMC-97104 NCI-G98-1468 CDR0000066501 ( Other Identifier: NCI ) |
First Posted: | March 12, 2004 Key Record Dates |
Last Update Posted: | June 20, 2013 |
Last Verified: | October 2009 |
Keywords provided by Duke University:
recurrent adult brain tumor adult anaplastic oligodendroglioma |
Additional relevant MeSH terms:
Nervous System Neoplasms Central Nervous System Neoplasms Oligodendroglioma 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 Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |