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Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma

Primary Purpose

Brain and Central Nervous System Tumors

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

hydroxyurea

imatinib mesylate

About this trial

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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosed with meningioma
- WHO grade I-III
Recurrent or progressive disease after prior surgery and radiotherapy, or radiosurgery
Not amenable to further surgery
No optic nerve sheet tumor and neurofibromatosis type II
No known brain metastasis

PATIENT CHARACTERISTICS:

WHO performance status 0-2
ANC > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin ≥ 9 mg/dL (transfusion allowed)
Total bilirubin < 1.5 times upper limit of normal (ULN)
SGOT and SGPT < 2.5 times ULN
Creatinine < 1.5 times ULN
Negative pregnancy test
Fertile patients must use effective barrier method contraception during and for up to 3 months after completion of study therapy
No second malignancy
No known chronic liver disease (i.e., active hepatitis, cirrhosis)
No known HIV infection
No significant history of non-compliance to medical regimens or inability to grant reliable informed consent

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent enzyme-inducing anti-epileptic drugs
No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®)
- Low-molecular weight heparin (e.g., Lovenox) or heparin allowed
- Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician
No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib mesylate administration
No other concurrent anticancer agents, including chemotherapy or biological agents
No other concurrent investigational drugs

Sites / Locations

Ospedale Civile AvellinoRecruiting
Ospedale BellariaRecruiting
Azienda Ospedaliero CareggiRecruiting
Istituto Nazionale Neurologico Carlo BestaRecruiting
Ospedale Civile di RovigoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI

Secondary Outcome Measures

Survival

Response rate according to MacDonald criteria

Toxicity as assessed by NCI CTCAE v. 3.0

Full Information

NCT ID

NCT00904735

First Posted

May 19, 2009

Last Updated

August 9, 2013

Sponsor

Istituto Scientifico H. San Raffaele

1. Study Identification

Unique Protocol Identification Number

NCT00904735

Brief Title

Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma

Official Title

IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Istituto Scientifico H. San Raffaele

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma. PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.

Detailed Description

OBJECTIVES: Primary Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy. Secondary Determine the overall survival, and response rate of patients treated with this regimen. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs II-III). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed for up to 1 year.

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

adult grade I meningioma, adult grade II meningioma, adult anaplastic meningioma, adult papillary meningioma, recurrent adult brain tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

hydroxyurea

Intervention Description

Given orally

Intervention Type

Drug

Intervention Name(s)

imatinib mesylate

Intervention Description

Given orally

Primary Outcome Measure Information:

Title

Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI

Secondary Outcome Measure Information:

Title

Survival

Title

Response rate according to MacDonald criteria

Title

Toxicity as assessed by NCI CTCAE v. 3.0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosed with meningioma WHO grade I-III Recurrent or progressive disease after prior surgery and radiotherapy, or radiosurgery Not amenable to further surgery No optic nerve sheet tumor and neurofibromatosis type II No known brain metastasis PATIENT CHARACTERISTICS: WHO performance status 0-2 ANC > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin ≥ 9 mg/dL (transfusion allowed) Total bilirubin < 1.5 times upper limit of normal (ULN) SGOT and SGPT < 2.5 times ULN Creatinine < 1.5 times ULN Negative pregnancy test Fertile patients must use effective barrier method contraception during and for up to 3 months after completion of study therapy No second malignancy No known chronic liver disease (i.e., active hepatitis, cirrhosis) No known HIV infection No significant history of non-compliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent enzyme-inducing anti-epileptic drugs No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®) Low-molecular weight heparin (e.g., Lovenox) or heparin allowed Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib mesylate administration No other concurrent anticancer agents, including chemotherapy or biological agents No other concurrent investigational drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alba A. Brandes, MD

Organizational Affiliation

Ospedale Bellaria

Official's Role

Study Chair

Facility Information:

Facility Name

Ospedale Civile Avellino

City

Avellino

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Contact Person

Phone

39-0825-203-232

Facility Name

Ospedale Bellaria

City

Bologna

ZIP/Postal Code

I-40139

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alba A. Brandes, MD

Phone

39-51-622-5102

aa.brandes@yahoo.it

Facility Name

Azienda Ospedaliero Careggi

City

Florence

ZIP/Postal Code

50139

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Contact Person

Phone

39-055-427-7111

Facility Name

Istituto Nazionale Neurologico Carlo Besta

City

Milan

ZIP/Postal Code

20133

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Contact Person

Phone

39-02-2394-2341

Facility Name

Ospedale Civile di Rovigo

City

Rovigo

ZIP/Postal Code

45100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Contact Person

Phone

39-0425-393-016

12. IPD Sharing Statement

Learn more about this trial

Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma

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