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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00003292
Other study ID # CDR0000066225
Secondary ID S9624U10CA032102
Status Terminated
Phase Phase 2
First received November 1, 1999
Last updated November 7, 2013
Start date July 1998
Est. completion date January 2004

Study information

Verified date November 2013
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date January 2004
Est. primary completion date January 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ifosfamide


Locations

Country Name City State
Australia Westmead Hospital Westmead New South Wales
Peru Instituto de Enfermedades Neoplasicas Lima
Puerto Rico MBCCOP - San Juan San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico Veterans Affairs Medical Center - San Juan San Juan
United States MBCCOP - University of New Mexico HSC Albuquerque New Mexico
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Tuft-New England Medical Center Boston Massachusetts
United States Albert Einstein Clinical Cancer Center Bronx New York
United States Veterans Affairs Medical Center - Brooklyn Brooklyn New York
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States CCOP - Columbus Columbus Ohio
United States CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania
United States CCOP - Central Illinois Decatur Illinois
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center Des Moines Iowa
United States City of Hope Comprehensive Cancer Center Duarte California
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States CCOP - Evanston Evanston Illinois
United States CCOP - Merit Care Hospital Fargo North Dakota
United States Veterans Affairs Medical Center - Fargo Fargo North Dakota
United States Veterans Affairs Medical Center - Gainesville Gainesville Florida
United States CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States Indiana University Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana
United States CCOP - Kalamazoo Kalamazoo Michigan
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States Veterans Affairs Medical Center - Madison Madison Wisconsin
United States CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin
United States Medical College of Wisconsin Cancer Center Milwaukee Wisconsin
United States Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York
United States Veterans Affairs Medical Center - New York New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Veterans Affairs Medical Center - Palo Alto Palo Alto California
United States Alegent Health-Midlands Community Hospital Papillion Nebraska
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Drexel University Hospital Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania
United States James P. Wilmot Cancer Center Rochester New York
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States Stanford University Medical Center Stanford California
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida
United States CCOP - Oklahoma Tulsa Oklahoma
United States CCOP - Carle Cancer Center Urbana Illinois
United States CCOP - MainLine Health Wynnewood Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Southwest Oncology Group Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

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