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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00052455
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Institute of Cancer Research, United Kingdom
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Simon Clawson
Principal Investigator Affiliation Medical Research Council
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Compare the efficacy of temozolomide vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

London, England, United Kingdom

Status

Address

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA

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