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Ifosfamide in Treating Patients With Meningeal Tumors
This study has been withdrawn prior to recruitment.
First Received: November 1, 1999   Last Updated: January 11, 2007   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003292
  Purpose

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.


Condition Intervention Phase
Chondrosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Rhabdomyosarcoma
Adult Malignant Meningioma
Adult Brain Malignant Hemangiopericytoma
Drug: ifosfamide
Procedure: chemotherapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003292

  Show 70 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: Leslie McAllister, MD Neurological Clinic
Study Chair: Lynn G. Feun, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

No publications provided

Study ID Numbers: CDR0000066225, SWOG-S9624, E-S9624, NABTT-S9624
Study First Received: November 1, 1999
Last Updated: January 11, 2007
ClinicalTrials.gov Identifier: NCT00003292     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Fibrosarcoma
Neoplasms, Muscle Tissue
Meningeal Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Leiomyosarcoma
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Therapeutic Uses
Chondrosarcoma
Neoplasms, Vascular Tissue
Meningioma
Alkylating Agents
Nervous System Neoplasms
Rhabdomyosarcoma
Neoplasms by Histologic Type
Myosarcoma
Nervous System Diseases
Hemangiopericytoma
Pharmacologic Actions
Neoplasms
Ifosfamide
Sarcoma
Neoplasms, Connective Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Fibrous Tissue
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 22, 2009