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S9624 Ifosfamide in Treating Patients With Meningeal Tumors

This study has been terminated.
(lack of accrual)
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003292
First received: November 1, 1999
Last updated: November 7, 2013
Last verified: November 2013
  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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S9624: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Enrollment: 7
Study Start Date: July 1998
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ifosfamide
ifosfamide
Drug: ifosfamide

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003292     History of Changes
Other Study ID Numbers: CDR0000066225, S9624, U10CA032102
Study First Received: November 1, 1999
Last Updated: November 7, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 27, 2014