Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
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
History of Changes
  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: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival at 12 weeks (Arm II) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life as measured by EORTC QLQ-C30 and BTM [ Designated as safety issue: No ]
  • Cost effectiveness [ Designated as safety issue: No ]
Estimated Enrollment: 500
Study Start Date: October 2002
Study Completion Date: September 2010
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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
Health Authority: United States: Federal Government

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:
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Procarbazine
Temozolomide
 Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015