S9624 Ifosfamide in Treating Patients With Meningeal Tumors

November 7, 2013 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
  • Peru
      • Lima, Peru, 34
        • Instituto De Enfermedades Neoplasicas
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-7344
        • San Juan City Hospital
      • San Juan, Puerto Rico, 00927-5800
        • MBCCOP - San Juan
      • San Juan, Puerto Rico, 00927-5800
        • Veterans Affairs Medical Center - San Juan
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304-1290
        • Veterans Affairs Medical Center - Palo Alto
      • Stanford, California, United States, 94305-5216
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program, Incorporated
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Gainesville, Florida, United States, 32608-1197
        • Veterans Affairs Medical Center - Gainesville
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
      • Tampa, Florida, United States, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Illinois
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Evanston, Illinois, United States, 60201
        • CCOP - Evanston
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center
      • Des Moines, Iowa, United States, 50316-2301
        • Iowa Lutheran Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney kimmel comprehensive cancer center at johns hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tuft-New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
      • Minneapolis, Minnesota, United States, 55417-2399
        • Veterans Affairs Medical Center - Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Papillion, Nebraska, United States, 68128-4157
        • Alegent Health-Midlands Community Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, United States, 07019
        • Veterans Affairs Medical Center - East Orange
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Clinical Cancer Center
      • Brooklyn, New York, United States, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10010
        • Veterans Affairs Medical Center - New York
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Veterans Affairs Medical Center - Fargo
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • CCOP - Oklahoma
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Drexel University Hospital
      • Pittsburgh, Pennsylvania, United States, 15240
        • Veterans Affairs Medical Center - Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15236
        • University of Pittsburgh Cancer Institute
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Madison, Wisconsin, United States, 53705
        • Veterans Affairs Medical Center - Madison
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Medical Research and Education Foundation
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
      • Milwaukee, Wisconsin, United States, 53226-3596
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ifosfamide
Drug: ifosfamide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066225
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S9624 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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