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

Phase 2
18 Years
Not Enrolling
Chondrosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Rhabdomyosarcoma, Adult Malignant Meningioma, Adult Brain Malignant Hemangiopericytoma

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Trial Information

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


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Not specified


- Creatinine no greater than 2.0 mg/dL


- No myocardial infarction within the past 3 months

- No active angina

- No unstable heart rhythms

- No congestive heart failure


- 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


- Recovered from toxic effects of prior therapy and/or from postoperative complications

Biologic therapy:

- Not specified


- 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


- At least 4 weeks since prior radiotherapy

- Progressive disease following radiation required

- No concurrent radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Leslie McAllister, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Neurological Clinic


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

January 2004

Related Keywords:

  • Chondrosarcoma
  • Adult Fibrosarcoma
  • Adult Leiomyosarcoma
  • Adult Rhabdomyosarcoma
  • Adult Malignant Meningioma
  • Adult Brain Malignant Hemangiopericytoma
  • Chondrosarcoma
  • Fibrosarcoma
  • Hemangiopericytoma
  • Leiomyosarcoma
  • Meningeal Neoplasms
  • Meningioma
  • Rhabdomyosarcoma



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