Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006119
First received: August 3, 2000
Last updated: July 23, 2008
Last verified: December 2004
  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 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Study Chair: Didier Frappaz, MD Centre Leon Berard
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006119     History of Changes
Other Study ID Numbers: CDR0000068132, FRE-FNCLCC-98009, EU-20018
Study First Received: August 3, 2000
Last Updated: July 23, 2008
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:
Nervous System Neoplasms
Central Nervous System Neoplasms
Meningioma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014