S9624 Ifosfamide in Treating Patients With Meningeal Tumors

SWOG Cancer Research Network

Status and phase: Terminated; Phase 2

Conditions: Adult Brain Malignant Hemangiopericytoma; Adult Fibrosarcoma; Adult Malignant Meningioma; Chondrosarcoma; Adult Rhabdomyosarcoma; Adult Leiomyosarcoma

Treatments: Drug: ifosfamide

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003292

S9624 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

CDR0000066225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

7 participants in 1 patient group

ifosfamide

Experimental group

Description:

ifosfamide

Treatment:

Drug: ifosfamide