Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006119
• Other study ID #: CDR0000068132
• Secondary ID: FRE-FNCLCC-98009
• Status: Completed
• Phase: Phase 2
• Start date: July 1999
• Est. completion date: January 2008

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Meningioma
• Nervous System Neoplasms

Intervention

Drug:
• hydroxyurea

Locations

Country	Name	City	State
France	Hopital Saint Andre	Bordeaux
France	Centre Leon Berard	Lyon
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Eugene Marquis	Rennes
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France,