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Phase III Randomized Study of Temozolomide Versus Procarbazine, Lomustine, and Vincristine in Patients With Recurrent Malignant Glioma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Other
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MRC-BR12
EU-20114, ISRCTN83176944, NCT00052455
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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.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - No prior chemotherapy for glioma
Endocrine therapy 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
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
Expected Enrollment 500A total of 500 patients (250 per treatment arm) will be accrued for this study. Outcomes Primary Outcome(s)Overall survival
Secondary Outcome(s)Progression-free survival at 12 weeks (Arm II)
Toxicity
Overall survival
Quality of life as measured by EORTC QLQ-C30 and BTM
Cost effectiveness
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:
- 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
Trial Contact Information
Trial Lead Organizations Institute of Cancer Research - London | | | | Simon Clawson, Protocol chair | | | |
Trial Sites
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| England |
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London |
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| | | | | Medical Research Council Clinical Trials Unit |
| | | Simon Clawson | |
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| Registry Information | | | Official Title | | A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV | | | Trial Start Date | | 2002-10-01 | | | Registered in ClinicalTrials.gov | | NCT00052455 | | | Date Submitted to PDQ | | 2002-09-30 | | | Information Last Verified | | 2007-05-23 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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