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

Sponsor:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006119

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: hydroxyurea	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Hydroxyurea

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 1999

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

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006119

Locations

France
Centre Eugene Marquis
Rennes, France, 35042
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Leon Berard
Lyon, France, 69373
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Hopital Saint Andre
Bordeaux, France, 33075

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Didier Frappaz, MD

Centre Leon Berard

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068132, FRE-FNCLCC-98009, EU-20018
Study First Received:	August 3, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00006119 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult brain tumor
adult grade III meningioma
adult grade I meningioma
adult grade II meningioma

Additional relevant MeSH terms:

Meningeal Neoplasms
Antisickling Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Hydroxyurea
Antineoplastic Agents
Hematologic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors

Central Nervous System Neoplasms
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Vascular Tissue
Meningioma
Nucleic Acid Synthesis Inhibitors
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009