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Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003304
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 recurrent oligodendroglial tumors following combination chemotherapy.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: temozolomide Phase 2

Detailed Description:

OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.

OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Primary Purpose: Treatment
Official Title: Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy
Study Start Date : April 1998
Actual Primary Completion Date : March 2000

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma (with at least 25% oligodendroglial elements) Recurrent or progressive disease following both radiotherapy and procarbazine/lomustine/vincristine chemotherapy (or other nitrosoureas-based chemotherapy) Contrast enhancing, measurable disease (at least one lesion measuring at least 1 cm) by CT or MRI required Within 2 weeks prior to study treatment Within 3 days following concurrent surgery for the recurrence Steroid doses stable or decreasing for at least 2 weeks prior to scan No extracranial disease

PATIENT CHARACTERISTICS: Age: 18-69 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance at least 60 mL/min Other: Not pregnant or lactating Effective contraception required of fertile women No diseases interfering with follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than one prior chemotherapy regimen At least 4 weeks since prior chemotherapy Prior nitrosourea required At least 6 weeks since nitrosourea Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics More than 3 months since radiotherapy Surgery: Not specified Other: No concurrent treatment with other investigational agents or other antitumor agents

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003304

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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Martin J. van Den Bent, MD Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publications of Results:
Other Publications:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003304    
Other Study ID Numbers: EORTC-26972
First Posted: August 26, 2004    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult oligodendroglioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents