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S9624 Ifosfamide in Treating Patients With Meningeal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003292
Recruitment Status : Terminated (lack of accrual)
First Posted : January 27, 2003
Last Update Posted : November 8, 2013
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group

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

Condition or disease Intervention/treatment Phase
Chondrosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Rhabdomyosarcoma Adult Malignant Meningioma Adult Brain Malignant Hemangiopericytoma Drug: ifosfamide Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: S9624: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors
Study Start Date : July 1998
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Arm Intervention/treatment
Experimental: ifosfamide
Drug: ifosfamide

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003292

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
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Study Chair: Leslie McAllister, MD Neurological Clinic
Study Chair: Lynn G. Feun, MD University of Miami Sylvester Comprehensive Cancer Center
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Responsible Party: Southwest Oncology Group Identifier: NCT00003292    
Other Study ID Numbers: CDR0000066225
S9624 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Meningeal Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents