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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-26972 |
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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 recurrent oligodendroglial tumors following combination chemotherapy.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Martin J. van Den Bent, MD | Daniel Den Hoed Cancer Center at Erasmus Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Franz Josef Hospital | Vienna (Wien) | A-1100 | Austria | |||
| Hopital Universitaire Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16914310 | Background | Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. doi: 10.1016/j.ejca.2006.05.021. Epub 2006 Aug 17. | |
| 12649108 |
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| Brussels |
| 1070 |
| Belgium |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Helsinki University Central Hospital | Helsinki | FIN-0-0029 | Finland |
| Turku University Central Hospital | Turku | FIN-2-0521 | Finland |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Hopital Louis Pasteur | Colmar | 68024 | France |
| Centre Hospitalier Universitaire de Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| CHU de la Timone | Marseille | 13385 | France |
| CHU de Nancy - Hopital Neurologique | Nancy | 54035 | France |
| CRLCC Nantes - Atlantique | Nantes-Saint Herblain | 44805 | France |
| Hopital Pasteur | Nice | 06002 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| C.H.R. de Nimes - Hopital Caremeau | Nîmes | 30000 | France |
| CHU Pitie-Salpetriere | Paris | 75651 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| Universitaetsklinikum Benjamin Franklin | Berlin | D-12200 | Germany |
| Neurologische Klinik der Henriettenstiftung | Hanover | D-30559 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | D-72076 | Germany |
| National Institute of Neurosurgery | Budapest | 1145 | Hungary |
| Azienda Ospedaliera di Padova | Padova (Padua) | 35128 | Italy |
| Universita Degli Studi di Torino | Torino | 10126 | Italy |
| Academisch Ziekenhuis der Vrije Universiteit | Amsterdam | 1007 MB | Netherlands |
| Antoni van Leeuwenhoekhuis | Amsterdam | 1066 CX | Netherlands |
| Academisch Ziekenhuis Groningen | Groningen | 9713 EZ | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| St. Radboud University Hospital | Nijmegen | 6500 HB | Netherlands |
| Rotterdam Cancer Institute | Rotterdam | 3075 EA | Netherlands |
| St. Elisabeth Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| Dr. Bernard Verbeeten Instituut | Tilburg | 5042 SB | Netherlands |
| Academisch Ziekenhuis Utrecht | Utrecht | 3508 GA | Netherlands |
| Instituto Portugues de Oncologia de Francisco Gentil | Lisbon | 1093 | Portugal |
| Umea Universitet | Umeå | S-901 85 | Sweden |
| Western General Hospital | Edinburgh | Scotland | EH4 9NQ | United Kingdom |
| Beatson Oncology Centre | Glasgow | Scotland | G11 6NT | United Kingdom |
| van den Bent MJ, Chinot O, Boogerd W, Bravo Marques J, Taphoorn MJ, Kros JM, van der Rijt CC, Vecht CJ, De Beule N, Baron B. Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. Ann Oncol. 2003 Apr;14(4):599-602. doi: 10.1093/annonc/mdg157. |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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