Hydroxyurea in Treating Patients With Recurrent and/or Un... | NCT00006119

Studies
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

NCT00006119

Sponsor

UNICANCER

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

Not provided

Phase

Phase 2

Conditions

Brain and Central Nervous System Tumors

Interventions

hydroxyurea

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1999Actual

Primary Completion Date

Dec 2004Actual

Completion Date

Jan 2008Actual

First Submitted Date

Aug 3, 2000

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2021

Last Update Posted Date

Feb 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
hydroxyurea	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Saint Andre		Bordeaux		33075	France
Centre Leon Berard

ID	Term
D016543	Central Nervous System Neoplasms
D001932	Brain Neoplasms
D008579	Meningioma

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases

ID	Term
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

ID	Type	Description	Link
FRE-FNCLCC-98009
EU-20018