S9624 Ifosfamide in Treating Patients With Meningeal Tumors

Chondrosarcoma Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Adult Brain Malignant Hemangiopericytoma
• Adult Fibrosarcoma
• Adult Leiomyosarcoma
• Adult Malignant Meningioma
• Adult Rhabdomyosarcoma
• Chondrosarcoma
• Fibrosarcoma
• Hemangiopericytoma
• Leiomyosarcoma
• Meningeal Neoplasms
• Meningioma
• Rhabdomyosarcoma
• Solitary Fibrous Tumors

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,