NCT00006119

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1999

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

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

July 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

5.4 years

First QC Date

August 3, 2000

Last Update Submit

February 19, 2021

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult grade III meningiomaadult grade I meningiomaadult grade II meningioma

Interventions

hydroxyureaDRUG

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven progressive meningioma that is not curable by surgery PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 70-100% Life expectancy: * Over 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than 2 times ULN Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study * No other malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed for control of intracranial pressure Radiotherapy: * Prior radiotherapy allowed * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 1 year since prior experimental therapy

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

Sponsors & Collaborators

Study Sites (5)

Hopital Saint Andre

Bordeaux, 33075, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsMeningioma

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Didier Frappaz, MD

    Centre Leon Berard

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

July 1, 1999

Primary Completion

December 1, 2004

Study Completion

January 1, 2008

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

FR(5)