Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003304
• Other study ID #: EORTC-26972
• Secondary ID: EORTC-26972
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 5, 2012
• Start date: April 1998

Study information

• Verified date: March 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna (Wien)
Belgium	Hopital Universitaire Erasme	Brussels
Denmark	Rigshospitalet	Copenhagen
Finland	Helsinki University Central Hospital	Helsinki
Finland	Turku University Central Hospital	Turku
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Hopital Louis Pasteur	Colmar
France	Centre Hospitalier Universitaire de Bicetre	Le Kremlin Bicetre
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	CHU de Nancy - Hopital Neurologique	Nancy
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	Hopital Pasteur	Nice
France	C.H.R. de Nimes - Hopital Caremeau	Nimes
France	CHU Pitie-Salpetriere	Paris
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Benjamin Franklin	Berlin
Germany	Neurologische Klinik der Henriettenstiftung	Hannover
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Hungary	National Institute of Neurosurgery	Budapest
Italy	Azienda Ospedaliera di Padova	Padova (Padua)
Italy	Universita Degli Studi di Torino	Torino
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	St. Radboud University Hospital	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Sweden	Umea Universitet	Umea
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Portugal,  Sweden,  United Kingdom, 

References & Publications (2)

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. Epub 2006 Aug 17. — View Citation

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) chem — View Citation