Clinical trial NCT00006119: Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
Official title: Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult grade III meningioma
adult grade I meningioma
adult grade II meningioma
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
Study officials:
affiliation: Centre Leon Berard
name: Didier Frappaz, MD
role: STUDY_CHAIR
References: