S9624 Ifosfamide in Treating Patients With Meningeal Tumors

Study Overview
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Brief Summary
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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 ifosfamide in treating patients with meningeal tumors that have recurred or that cannot be removed surgically.

Detailed Description
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OBJECTIVES: Estimate failure free survival, overall survival, and response in patients with residual or recurrent/progressive aggressive meningeal tumors (malignant meningioma, hemangiopericytoma, and primary nervous system sarcoma) treated with ifosfamide. Evaluate toxicities of ifosfamide in this patient population. OUTLINE: All patients receive ifosfamide IV continuously over 72 hours on days 1-3 of each 21 day treatment course. Patients are evaluated for response/progression after every 2 courses. Patients with stable disease receive up to 8 courses of therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.

Official Title
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S9624: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors

Conditions
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Chondrosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Rhabdomyosarcoma, Adult Malignant Meningioma, Adult Brain Malignant Hemangiopericytoma

Intervention / Treatment
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* Drug: ifosfamide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven recurrent or unresectable: Malignant meningioma Intracranial hemangiopericytoma Primary central nervous system sarcoma, including: Fibrosarcoma Rhabdomyosarcoma Chondrosarcoma Leiomyosarcoma Measurable or evaluable disease on CT or MRI scan Persistent disease following biopsy or incomplete resection OR Recurrent disease following complete resection No benign meningioma No prior or current systemic sarcoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 3 months No active angina No unstable heart rhythms No congestive heart failure Other: HIV negative No allergy to study drugs No serious concurrent medical or psychiatric illness No uncontrolled peptic ulcer disease No prior malignancy within past 5 years except adequately treated: Basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior therapy and/or from postoperative complications Biologic therapy: Not specified Chemotherapy: No prior ifosfamide No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except estrogen replacement therapy) Corticosteroids allowed if dose is stable or decreasing Radiotherapy: At least 4 weeks since prior radiotherapy Progressive disease following radiation required No concurrent radiotherapy Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ifosfamide<br>ifosfamide | Drug: ifosfamide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |