Ifosfamide in Treating Patients With Meningeal Tumors
This study has been terminated.
(lack of accrual)
Sponsor:
Southwest Oncology Group
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 19, 2012
Last verified: November 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003292
Show 70 Study Locations
Show 70 Study LocationsSponsors 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 19, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Chondrosarcoma Fibrosarcoma Hemangiopericytoma Leiomyosarcoma Meningeal Neoplasms Meningioma Rhabdomyosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Neoplasms, Fibrous Tissue Neoplasms, Vascular Tissue Neoplasms, Muscle Tissue |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Neoplasms, Nerve Tissue Myosarcoma Ifosfamide Isophosphamide mustard Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013