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S9624 Ifosfamide in Treating Patients With Meningeal Tumors

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003292
Enrollment
7
Registered
2003-01-27
Start date
1998-07-31
Completion date
2004-01-31
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Brain Malignant Hemangiopericytoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Malignant Meningioma, Adult Rhabdomyosarcoma, Chondrosarcoma

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.

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.

Interventions

DRUGifosfamide

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Eastern Cooperative Oncology Group
CollaboratorNETWORK
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Australia, Peru, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026