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Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma

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ClinicalTrials.gov Identifier: NCT00052455
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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.

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: lomustine Drug: procarbazine hydrochloride Drug: temozolomide Drug: vincristine sulfate Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Study Start Date : October 2002
Actual Study Completion Date : September 2010

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Progression-free survival at 12 weeks (Arm II)
  2. Toxicity
  3. Overall survival
  4. Quality of life as measured by EORTC QLQ-C30 and BTM
  5. Cost effectiveness

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications of Results:

ClinicalTrials.gov Identifier: NCT00052455     History of Changes
Other Study ID Numbers: CDR0000258428
MRC-BR12
EU-20114
ISRCTN83176944
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2007

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