Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma - Tabular View

Tracking Information

First Received Date ^ICMJE

August 3, 2000

Last Updated Date

July 23, 2008

Start Date ^ICMJE

July 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

Official Title ^ICMJE

Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma

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.

Detailed Description

OBJECTIVES:

Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma.
Determine response at 2 years to this regimen in these patients.
Determine overall and disease free survival of these patients after this regimen.
Determine quality of life of these patients.
Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III).

Patients receive oral hydroxyurea daily for 2 years.

Quality of life is assessed before treatment, then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Brain and Central Nervous System Tumors

Intervention ^ICMJE

Drug: hydroxyurea

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00006119

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068132, FRE-FNCLCC-98009, EU-20018

Study Sponsor ^ICMJE

Federation Nationale des Centres de Lutte Contre le Cancer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Didier Frappaz, MD

Centre Leon Berard

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP