Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

Sponsor

UNICANCER (Other)

Overall Status

Completed

CT.gov ID

NCT00006119

Collaborator

(none)

Locations

102

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: hydroxyurea	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 1999

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital Saint Andre	Bordeaux	France	33075
2	Centre Leon Berard	Lyon	France	69373
3	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier	France	34298
4	Centre Eugene Marquis	Rennes	France	35042
5	Centre Hospitalier Universitaire Bretonneau de Tours	Tours	France	37044