Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003292




Registration number
NCT00003292
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
8/11/2013

Titles & IDs
Public title
S9624 Ifosfamide in Treating Patients With Meningeal Tumors
Scientific title
S9624: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors
Secondary ID [1] 0 0
S9624
Secondary ID [2] 0 0
CDR0000066225
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chondrosarcoma 0 0
Adult Fibrosarcoma 0 0
Adult Leiomyosarcoma 0 0
Adult Rhabdomyosarcoma 0 0
Adult Malignant Meningioma 0 0
Adult Brain Malignant Hemangiopericytoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other
Neurological 0 0 0 0
Other neurological disorders
Cancer 0 0 0 0
Any cancer
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ifosfamide

Experimental: ifosfamide - ifosfamide


Treatment: Drugs: ifosfamide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2004
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Peru
State/province [26] 0 0
Lima
Country [27] 0 0
Puerto Rico
State/province [27] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
SWOG Cancer Research Network
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Cooperative Oncology Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leslie McAllister, MD
Address 0 0
Neurological Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003292