Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

hydroxyurea

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult grade III meningioma, adult grade I meningioma, adult grade II meningioma

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Saint Andre
Centre Leon Berard
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Centre Eugene Marquis
Centre Hospitalier Universitaire Bretonneau de Tours

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006119

First Posted

August 3, 2000

Last Updated

February 19, 2021

Sponsor

UNICANCER

1. Study Identification

Unique Protocol Identification Number

NCT00006119

Brief Title

Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 1999 (Actual)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

hydroxyurea

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Frappaz, MD

Organizational Affiliation

Centre Leon Berard

Official's Role

Study Chair

Facility Information:

Facility Name

Hopital Saint Andre

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

Centre Eugene Marquis

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Centre Hospitalier Universitaire Bretonneau de Tours

City

Tours

ZIP/Postal Code

37044

Country

France

Brain and Central Nervous System Tumors

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial