S9624 Ifosfamide in Treating Patients With Meningeal Tumors

NCT00003292 | Terminated Phase 2 DMC

• 3 other identifiers: CDR0000066225S9624U10CA032102
• Study Type: interventional
• Target: 7
• Locations: 4 countries
• Sites: 70

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.

Conditions

Chondrosarcoma; Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Rhabdomyosarcoma; Adult Malignant Meningioma; Adult Brain Malignant Hemangiopericytoma

Study Arms (1)

ifosfamide

EXPERIMENTAL

ifosfamide

Drug: ifosfamide

Interventions

ifosfamide DRUG

ifosfamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (70)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, 94304-1290, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5216, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Veterans Affairs Medical Center - Gainesville

Gainesville, Florida, 32608-1197, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Tuft-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417-2399, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Alegent Health-Midlands Community Hospital

Papillion, Nebraska, 68128-4157, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07019, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Veterans Affairs Medical Center - Brooklyn

Brooklyn, New York, 11209, United States

Location

Veterans Affairs Medical Center - New York

New York, New York, 10010, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

Veterans Affairs Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Drexel University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15236, United States

Location

Veterans Affairs Medical Center - Pittsburgh

Pittsburgh, Pennsylvania, 15240, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

MBCCOP - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

San Juan City Hospital

San Juan, 00936-7344, Puerto Rico

Location

MeSH Terms

Conditions

Chondrosarcoma; Fibrosarcoma; Leiomyosarcoma; Rhabdomyosarcoma; Meningioma

Interventions

Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Leslie McAllister, MD

  Neurological Clinic

  STUDY CHAIR

• Lynn G. Feun, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1998
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

PE (1); US (65); PR (3); AU (1)