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Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma
This study has been completed.
Sponsor:
Institute of Cancer Research, United Kingdom
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052455
First received: January 24, 2003
Last updated: December 17, 2013
Last verified: May 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Drug: lomustine Drug: procarbazine hydrochloride Drug: temozolomide Drug: vincristine sulfate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Glioblastoma
Brain Tumor, Adult
Glioma
Gliosarcoma
Anaplastic Astrocytoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival
Secondary Outcome Measures:
- Progression-free survival at 12 weeks (Arm II)
- Toxicity
- Overall survival
- Quality of life as measured by EORTC QLQ-C30 and BTM
- Cost effectiveness
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2002 |
| Study Completion Date: | September 2010 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052455
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052455
Locations
| United Kingdom | |
| Medical Research Council Clinical Trials Unit | |
| London, England, United Kingdom, NW1 2DA | |
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
| Study Chair: | Simon Clawson | Medical Research Council |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00052455 History of Changes |
| Other Study ID Numbers: |
CDR0000258428 MRC-BR12 EU-20114 ISRCTN83176944 |
| Study First Received: | January 24, 2003 |
| Last Updated: | December 17, 2013 |
Keywords provided by National Cancer Institute (NCI):
|
adult glioblastoma adult anaplastic astrocytoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Temozolomide Dacarbazine Lomustine Vincristine |
Procarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on September 21, 2017