ChondrosarcomaPhase 2NCT00003292
S9624 Ifosfamide in Treating Patients With Meningeal Tumors
A Phase 2 study testing ifosfamide in people with Chondrosarcoma and Adult Fibrosarcoma, run by SWOG Cancer Research Network at 70 sites in 4 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondrosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma
- What is being tested?
- ifosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 70 sitesin 4 countries
- Study dates
- Jul 1998to Jan 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
70 sites in 4 countries.
70 sites in 4 countries
United States65 sites
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Tuft-New England Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Medical Center
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
CCOP - Evanston
Evanston, Illinois, 60201
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, 32608-1197
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226-3596
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417-2399
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Ochsner
New Orleans, Louisiana, 70121
Veterans Affairs Medical Center - New York
New York, New York, 10010
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304-1290
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, 68128-4157
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Drexel University Hospital
Philadelphia, Pennsylvania, 19102-1192
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
James P. Wilmot Cancer Center
Rochester, New York, 14642
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
Stanford University Medical Center
Stanford, California, 94305-5216
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
Albert Einstein Clinical Cancer Center
The Bronx, New York, 10461
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Puerto Rico3 sites
MBCCOP - San Juan
San Juan, 00927-5800
Veterans Affairs Medical Center - San Juan
San Juan, 00927-5800
San Juan City Hospital
San Juan, 00936-7344
About this study
Official title: 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.
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.
- Conditions
- Chondrosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Rhabdomyosarcoma, Adult Malignant Meningioma, Adult Brain Malignant Hemangiopericytoma
- Being tested
- ifosfamide
- Medical subject headings
- Chondrosarcoma, Fibrosarcoma, Leiomyosarcoma, Rhabdomyosarcoma, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ifosfamideDrug
| Study group | Role | What they receive |
|---|---|---|
| ifosfamide | Experimental | ifosfamide Receives: Drug: ifosfamide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 1998
- Primary completionJan 2004
- Study completionJan 2004
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChondrosarcomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Responsible party
- Sponsor
- Investigators
- Leslie McAllister, MD, Study chair, Neurological ClinicLynn G. Feun, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003292
- Sponsor's protocol ID
- CDR0000066225
- Other IDs
- S9624, U10CA032102
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 1999
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S9624: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors
- ClinicalTrials.gov ID
- NCT00003292
- Acronym / sponsor ID
- CDR0000066225
- Conditions
- Chondrosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Rhabdomyosarcoma, Adult Malignant Meningioma, Adult Brain Malignant Hemangiopericytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Study start
- Jul 1998
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ifosfamide | Experimental | Drug: ifosfamideifosfamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ifosfamide | Drug | ifosfamide |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie McAllister, MD study chair
Neurological Clinic
Lynn G. Feun, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
70 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ifosfamide in people with Chondrosarcoma and Adult Fibrosarcoma, run by SWOG Cancer Research Network at 70 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Puerto Rico, Australia, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.