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S9624 Ifosfamide in Treating Patients With Meningeal Tumors

Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00003292
Collaborator
National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other)
7
Enrollment
70
Locations
1
Arm
66
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
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 :
Jul 1, 1998
Actual Primary Completion Date :
Jan 1, 2004
Actual Study Completion Date :
Jan 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: ifosfamide

ifosfamide

Drug: ifosfamide

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    2 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    3 Veterans Affairs Medical Center - Palo Alto Palo Alto California United States 94304-1290
    4 Stanford University Medical Center Stanford California United States 94305-5216
    5 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224
    6 CCOP - Christiana Care Health Services Newark Delaware United States 19713
    7 Veterans Affairs Medical Center - Gainesville Gainesville Florida United States 32608-1197
    8 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    9 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    10 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    11 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    12 CCOP - Central Illinois Decatur Illinois United States 62526
    13 CCOP - Evanston Evanston Illinois United States 60201
    14 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
    15 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    16 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    17 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    18 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    19 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    20 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    21 Mercy Medical Center Des Moines Iowa United States 50314
    22 Iowa Lutheran Hospital Des Moines Iowa United States 50316-2301
    23 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    24 CCOP - Ochsner New Orleans Louisiana United States 70121
    25 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231
    26 Tuft-New England Medical Center Boston Massachusetts United States 02111
    27 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    28 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    29 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    30 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417-2399
    31 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    32 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    33 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    34 Alegent Health-Midlands Community Hospital Papillion Nebraska United States 68128-4157
    35 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    36 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07019
    37 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
    38 Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    39 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    40 Albert Einstein Clinical Cancer Center Bronx New York United States 10461
    41 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
    42 Veterans Affairs Medical Center - New York New York New York United States 10010
    43 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    44 James P. Wilmot Cancer Center Rochester New York United States 14642
    45 Veterans Affairs Medical Center - Fargo Fargo North Dakota United States 58102
    46 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    47 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    48 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    49 CCOP - Columbus Columbus Ohio United States 43206
    50 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    51 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    52 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    53 Drexel University Hospital Philadelphia Pennsylvania United States 19102-1192
    54 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    55 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    56 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15236
    57 Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania United States 15240
    58 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    59 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
    60 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54307-3453
    61 Veterans Affairs Medical Center - Madison Madison Wisconsin United States 53705
    62 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-0001
    63 CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin United States 54449
    64 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226-3596
    65 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    66 Westmead Hospital Westmead New South Wales Australia 2145
    67 Instituto de Enfermedades Neoplasicas Lima Peru 34
    68 MBCCOP - San Juan San Juan Puerto Rico 00927-5800
    69 Veterans Affairs Medical Center - San Juan San Juan Puerto Rico 00927-5800
    70 San Juan City Hospital San Juan Puerto Rico 00936-7344

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)
    • Eastern Cooperative Oncology Group

    Investigators

    • Study Chair: Leslie McAllister, MD, Neurological Clinic
    • Study Chair: Lynn G. Feun, MD, University of Miami Sylvester Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003292
    Other Study ID Numbers:
    • CDR0000066225
    • S9624
    • U10CA032102
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Nov 8, 2013
    Last Verified:
    Nov 1, 2013
    Additional relevant MeSH terms:
    Rhabdomyosarcoma
    Meningioma
    Leiomyosarcoma
    Chondrosarcoma
    Fibrosarcoma
    Hemangiopericytoma
    Solitary Fibrous Tumors
    Meningeal Neoplasms
    Ifosfamide

    Study Results

    No Results Posted as of Nov 8, 2013