Brain and Central Nervous System TumorsPhase 2NCT00003304
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 37 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- temozolomide
- How many people
- 29 participants
- Where
- 37 sitesin 12 countries
- Study dates
- Apr 1998to Mar 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
37 sites in 12 countries.
37 sites in 12 countries
France13 sites
Institut Bergonie
Bordeaux, 33076
Centre Regional Francois Baclesse
Caen, 14076
Hopital Louis Pasteur
Colmar, 68024
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicêtre, 94275
Centre Leon Berard
Lyon, 69373
CHU de la Timone
Marseille, 13385
CHU de Nancy - Hopital Neurologique
Nancy, 54035
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Hopital Pasteur
Nice, 06002
Centre Antoine Lacassagne
Nice, 06189
C.H.R. de Nimes - Hopital Caremeau
Nîmes, 30000
CHU Pitie-Salpetriere
Paris, 75651
Institut Gustave Roussy
Villejuif, F-94805
Netherlands9 sites
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, 1007 MB
Antoni van Leeuwenhoekhuis
Amsterdam, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, 9713 EZ
Academisch Ziekenhuis Maastricht
Maastricht, 6202 AZ
St. Radboud University Hospital
Nijmegen, 6500 HB
Rotterdam Cancer Institute
Rotterdam, 3075 EA
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC
Dr. Bernard Verbeeten Instituut
Tilburg, 5042 SB
Academisch Ziekenhuis Utrecht
Utrecht, 3508 GA
Germany3 sites
Universitaetsklinikum Benjamin Franklin
Berlin, D-12200
Neurologische Klinik der Henriettenstiftung
Hanover, D-30559
Universitaetsklinikum Tuebingen
Tübingen, D-72076
Finland2 sites
Helsinki University Central Hospital
Helsinki, FIN-0-0029
Turku University Central Hospital
Turku, FIN-2-0521
Italy2 sites
Azienda Ospedaliera di Padova
Padova (Padua), 35128
Universita Degli Studi di Torino
Torino, 10126
United Kingdom2 sites
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1093
About this study
Official title: Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- temozolomide
- Keywords
- adult oligodendroglioma
- Medical subject headings
- Central Nervous System Neoplasms, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startApr 1998
- Primary completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martin J. van Den Bent, MD, Study chair, Daniel Den Hoed Cancer Center at Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003304
- Sponsor's protocol ID
- EORTC-26972
- Other IDs
- EORTC-26972
- Status last verified
- Mar 2012
- First submitted
- 1 Nov 1999
- Last updated
- 6 Mar 2012
- Results posted
- No
Publications
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.
PubMed 16914310van 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.
PubMed 12649108
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy
- ClinicalTrials.gov ID
- NCT00003304
- Acronym / sponsor ID
- EORTC-26972
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult oligodendroglioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 1998
- Primary completion
- Mar 2000 (actual)
- First posted
- 26 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Background: PubMed 16914310Kouwenhoven 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.
- Results publication: PubMed 12649108van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin J. van Den Bent, MD study chair
Daniel Den Hoed Cancer Center at Erasmus Medical Center
37 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 37 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Netherlands, Germany, Finland, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.