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Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006119
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
Actual Study Start Date : July 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea





Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006119


Locations
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France
Hopital Saint Andre
Bordeaux, France, 33075
Centre Leon Berard
Lyon, France, 69373
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Eugene Marquis
Rennes, France, 35042
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Didier Frappaz, MD Centre Leon Berard
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00006119    
Other Study ID Numbers: CDR0000068132
FRE-FNCLCC-98009
EU-20018
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
recurrent adult brain tumor
adult grade III meningioma
adult grade I meningioma
adult grade II meningioma
Additional relevant MeSH terms:
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Meningioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors