Brain and Central Nervous System TumorsPhase 3NCT00052455
Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma
A Phase 3 study testing lomustine, procarbazine hydrochloride and temozolomide in people with Brain and Central Nervous System Tumors, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- lomustine, procarbazine hydrochloride and temozolomide
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2002to Sep 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma
- WHO grade III or IV at diagnosis or relapse
- Must have undergone primary therapy including radiotherapy
- Must be in first recurrence confirmed by CT scan or MRI
- Evaluable disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-3
Life expectancy
- At least 1 month
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Total and direct bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT less than 3 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
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent serious illness
- Considered fit to receive chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for glioma
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 2 months since prior radiotherapy
- No prior radiosurgery, interstitial radiotherapy, or brachytherapy for glioma
Surgery
- Prior debulking surgery for recurrent disease allowed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
About this study
Official title: A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of temozolomide vs procarbazine, lomustine, and vincristine, in terms of overall survival, in patients with recurrent malignant glioma.
- Compare progression-free survival of patients treated with these regimens.
- Compare progression-free survival at 12 weeks in patients treated with two different schedules of temozolomide.
- Compare the overall survival of patients treated with two different schedules of temozolomide.
- Compare toxic effects of two different schedules of temozolomide in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I:Patients are randomized to 1 of 2 treatment schedules:
- Schedule 1: Patients receive oral temozolomide once daily on days 1-5.
- Schedule 2:Patients receive oral temozolomide once daily on days 1-21. Treatment on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence of disease progression or unacceptable toxicity.
- Arm II:Patients receive oral lomustine and vincristine IV on day 1 and oral procarbazine on days 1-21. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at 12 and 24 weeks.
Patients are followed every 12 weeks.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- lomustine, procarbazine hydrochloride, temozolomide, vincristine sulfate
- Keywords
- adult glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Astrocytoma, Brain Neoplasms, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lomustineDrug
procarbazine hydrochlorideDrug
temozolomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (5)
Progression-free survival at 12 weeks (Arm II)
Toxicity
Overall survival
Quality of life as measured by EORTC QLQ-C30 and BTM
Cost effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2002
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Institute of Cancer Research, United KingdomThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Simon Clawson, Study chair, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052455
- Sponsor's protocol ID
- CDR0000258428
- Other IDs
- MRC-BR12, EU-20114, ISRCTN83176944
- Status last verified
- May 2007
- First submitted
- 24 Jan 2003
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
Brada M, Stenning S, Gabe R, Thompson LC, Levy D, Rampling R, Erridge S, Saran F, Gattamaneni R, Hopkins K, Beall S, Collins VP, Lee SM. Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. J Clin Oncol. 2010 Oct 20;28(30):4601-8. doi: 10.1200/JCO.2009.27.1932. Epub 2010 Sep 20.
PubMed 20855843
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
- ClinicalTrials.gov ID
- NCT00052455
- Acronym / sponsor ID
- CDR0000258428
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Jan 2003 (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. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.
Detailed description
OBJECTIVES:
- Compare the efficacy of temozolomide vs procarbazine, lomustine, and vincristine, in terms of overall survival, in patients with recurrent malignant glioma.
- Compare progression-free survival of patients treated with these regimens.
- Compare progression-free survival at 12 weeks in patients treated with two different schedules of temozolomide.
- Compare the overall survival of patients treated with two different schedules of temozolomide.
- Compare toxic effects of two different schedules of temozolomide in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I:Patients are randomized to 1 of 2 treatment schedules:
- Schedule 1: Patients receive oral temozolomide once daily on days 1-5.
- Schedule 2:Patients receive oral temozolomide once daily on days 1-21. Treatment on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence of disease progression or unacceptable toxicity.
- Arm II:Patients receive oral lomustine and vincristine IV on day 1 and oral procarbazine on days 1-21. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at 12 and 24 weeks.
Patients are followed every 12 weeks.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| lomustine | Drug | – |
| procarbazine hydrochloride | Drug | – |
| temozolomide | Drug | – |
| vincristine sulfate | Drug | – |
Primary outcome
Overall survival
5 secondary outcomes
Progression-free survival at 12 weeks (Arm II)
Toxicity
Overall survival
Quality of life as measured by EORTC QLQ-C30 and BTM
Cost effectiveness
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 18 Dec 2013.
- Results publication: PubMed 20855843Brada M, Stenning S, Gabe R, Thompson LC, Levy D, Rampling R, Erridge S, Saran F, Gattamaneni R, Hopkins K, Beall S, Collins VP, Lee SM. Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. J Clin Oncol. 2010 Oct 20;28(30):4601-8. doi: 10.1200/JCO.2009.27.1932. Epub 2010 Sep 20.
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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.
Simon Clawson study chair
Medical Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lomustine, procarbazine hydrochloride and temozolomide in people with Brain and Central Nervous System Tumors, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00052455, which also lists 1 linked publication.
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 18 Dec 2013.