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


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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000066225

NCT ID:

NCT00003292

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

Name

Location

Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Ireland Cancer Center Cleveland, Ohio  44106-5065
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
CCOP - Oklahoma Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
James P. Wilmot Cancer Center Rochester, New York  14642
City of Hope Comprehensive Cancer Center Duarte, California  91010
Iowa Methodist Medical Center Des Moines, Iowa  50309
Mercy Medical Center Des Moines, Iowa  50314
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Tuft-New England Medical Center Boston, Massachusetts  02111
Alegent Health-Midlands Community Hospital Papillion, Nebraska  68128-4157
Albert Einstein Clinical Cancer Center Bronx, New York  10461
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Drexel University Hospital Philadelphia, Pennsylvania  19102-1192
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Veterans Affairs Medical Center - Gainesville Gainesville, Florida  32608-1197