NCT00052455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 18, 2013

Status Verified

May 1, 2007

First QC Date

January 24, 2003

Last Update Submit

December 17, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult anaplastic astrocytomarecurrent adult brain tumoradult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (5)

  • Progression-free survival at 12 weeks (Arm II)

  • Toxicity

  • Overall survival

  • Quality of life as measured by EORTC QLQ-C30 and BTM

  • Cost effectiveness

Interventions

lomustineDRUG
procarbazine hydrochlorideDRUG
temozolomideDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Related Publications (1)

  • Brada M, Stenning S, Gabe R, Thompson LC, Levy D, Rampling R, Erridge S, Saran F, Gattamaneni R, Hopkins K, Beall S, Collins VP, Lee SM. Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. J Clin Oncol. 2010 Oct 20;28(30):4601-8. doi: 10.1200/JCO.2009.27.1932. Epub 2010 Sep 20.

    PMID: 20855843RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaAstrocytomaBrain NeoplasmsGliosarcoma

Interventions

LomustineProcarbazineTemozolomideVincristine

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsBenzamidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Simon Clawson

    Medical Research Council

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Study Completion

September 1, 2010

Last Updated

December 18, 2013

Record last verified: 2007-05

Locations

GB(1)