ClinicalTrials.gg
TerminatedNCT00003292Updated Nov 8, 2013

S9624 Ifosfamide in Treating Patients With Meningeal Tumors

A Phase 2 interventional study of ifosfamide in Chondrosarcoma, Adult Fibrosarcoma and Adult Leiomyosarcoma, sponsored by SWOG Cancer Research Network. Terminated at 70 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Why this study was terminated
lack of accrual
Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chondrosarcoma
  • Adult Fibrosarcoma
  • Adult Leiomyosarcoma
  • Adult Rhabdomyosarcoma
  • Adult Malignant Meningioma
  • Adult Brain Malignant Hemangiopericytoma
03

In context

Chondrosarcoma

99 studies on the registry are indexed under Chondrosarcoma; 20 are open to participants now.

This study's enrollment of 7 is below the median of 52 across 72 interventional studies indexed under Chondrosarcoma.

Browse Chondrosarcoma studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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 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

:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm\^3
  • Absolute granulocyte count at least 1,500/mm\^3
  • 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:

  • negative
  • No allergy to study drugs
  • No serious concurrent medical or psychiatric illness
  • No uncontrolled peptic ulcer disease
  • No prior 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 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)
  • 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
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    ifosfamide

    ifosfamide

    Drug: ifosfamide

Interventions

06

Study locations

70 sites
  • CCOP - Scottsdale Oncology Program
    Scottsdale, Arizona 85259-5404, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • Veterans Affairs Medical Center - Palo Alto
    Palo Alto, California 94304-1290, United States
  • Stanford University Medical Center
    Stanford, California 94305-5216, United States
  • CCOP - Colorado Cancer Research Program, Incorporated
    Denver, Colorado 80224, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Veterans Affairs Medical Center - Gainesville
    Gainesville, Florida 32608-1197, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
  • Veterans Affairs Medical Center - Tampa (Haley)
    Tampa, Florida 33612, United States
  • Emory University Hospital - Atlanta
    Atlanta, Georgia 30322, United States
  • Veterans Affairs Medical Center - Atlanta (Decatur)
    Decatur, Georgia 30033, United States
  • CCOP - Central Illinois
    Decatur, Illinois 62526, United States
  • CCOP - Evanston
    Evanston, Illinois 60201, United States
  • CCOP - Illinois Oncology Research Association
    Peoria, Illinois 61602, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    Indianapolis, Indiana 46202, United States
  • CCOP - Cedar Rapids Oncology Project
    Cedar Rapids, Iowa 52403-1206, United States
  • CCOP - Iowa Oncology Research Association
    Des Moines, Iowa 50309-1016, United States
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Mercy Medical Center
    Des Moines, Iowa 50314, United States
  • Iowa Lutheran Hospital
    Des Moines, Iowa 50316-2301, United States
  • MBCCOP - LSU Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • CCOP - Ochsner
    New Orleans, Louisiana 70121, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231, United States
  • Tuft-New England Medical Center
    Boston, Massachusetts 02111, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan 48106, United States
  • CCOP - Kalamazoo
    Kalamazoo, Michigan 49007-3731, United States
  • Veterans Affairs Medical Center - Minneapolis
    Minneapolis, Minnesota 55417-2399, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • CCOP - Missouri Valley Cancer Consortium
    Omaha, Nebraska 68106, United States
  • Alegent Health-Midlands Community Hospital
    Papillion, Nebraska 68128-4157, United States
  • CCOP - Southern Nevada Cancer Research Foundation
    Las Vegas, Nevada 89106, United States
  • Veterans Affairs Medical Center - East Orange
    East Orange, New Jersey 07019, United States
  • CCOP - Northern New Jersey
    Hackensack, New Jersey 07601, United States
  • Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
  • MBCCOP - University of New Mexico HSC
    Albuquerque, New Mexico 87131, United States
  • Albert Einstein Clinical Cancer Center
    Bronx, New York 10461, United States
  • Veterans Affairs Medical Center - Brooklyn
    Brooklyn, New York 11209, United States
  • Veterans Affairs Medical Center - New York
    New York, New York 10010, United States
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
    New York, New York 10016, United States
  • James P. Wilmot Cancer Center
    Rochester, New York 14642, United States
  • Veterans Affairs Medical Center - Fargo
    Fargo, North Dakota 58102, United States
  • CCOP - Merit Care Hospital
    Fargo, North Dakota 58122, United States
  • Ireland Cancer Center
    Cleveland, Ohio 44106-5065, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • CCOP - Columbus
    Columbus, Ohio 43206, United States
  • CCOP - Oklahoma
    Tulsa, Oklahoma 74136, United States
  • CCOP - Geisinger Clinic and Medical Center
    Danville, Pennsylvania 17822-2001, United States
  • Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
  • Drexel University Hospital
    Philadelphia, Pennsylvania 19102-1192, United States
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    Philadelphia, Pennsylvania 19107-5541, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • University of Pittsburgh Cancer Institute
    Pittsburgh, Pennsylvania 15236, United States
  • Veterans Affairs Medical Center - Pittsburgh
    Pittsburgh, Pennsylvania 15240, United States
  • CCOP - MainLine Health
    Wynnewood, Pennsylvania 19096, United States
  • CCOP - Sioux Community Cancer Consortium
    Sioux Falls, South Dakota 57104, United States
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
    Green Bay, Wisconsin 54307-3453, United States
  • Veterans Affairs Medical Center - Madison
    Madison, Wisconsin 53705, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-0001, United States
  • CCOP - Marshfield Medical Research and Education Foundation
    Marshfield, Wisconsin 54449, United States
  • Medical College of Wisconsin Cancer Center
    Milwaukee, Wisconsin 53226-3596, United States
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    Milwaukee, Wisconsin 53295, United States
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Instituto de Enfermedades Neoplasicas
    Lima, 34, Peru
  • MBCCOP - San Juan
    San Juan, 00927-5800, Puerto Rico
  • Veterans Affairs Medical Center - San Juan
    San Juan, 00927-5800, Puerto Rico
  • San Juan City Hospital
    San Juan, 00936-7344, Puerto Rico
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 1998, a primary completion of Jan 2004 and a completion of Jan 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 1999
First posted
Jan 27, 2003
Start
Jul 1998
Primary completionActual
Jan 2004
CompletionActual
Jan 2004
Last update
Nov 8, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00003292
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jul 1998
Primary completion
Jan 2004
Completion
Jan 2004
Last update
Nov 8, 2013

Study contacts

Leslie McAllister, MD
study chair · Neurological Clinic
Lynn G. Feun, MD
study chair · University of Miami Sylvester Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ifosfamide

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