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Phase III Pilot Randomized Study of Filgrastim-SD/01 Versus Filgrastim (G-CSF) With Concurrent Chemotherapy in Patients With Newly Diagnosed Sarcoma
Alternate Title Basic Trial Information Objectives Entry Criteria Projected Accrual Outline Trial Contact Information
Alternate Title
Filgrastim Compared With Filgrastim-SD/01 Following Combination Chemotherapy in Treating Patients With Newly Diagnosed Sarcoma
Basic Trial Information
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Phase
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Supportive care, Treatment
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Active
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25 and under at diagnosis
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NCI
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NCI-00-C-0092F AMGEN-20000124
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Special Category:
NIH Clinical Center trial Objectives - Compare the toxicity of filgrastim-SD/01 vs filgrastim (G-CSF) administered with concurrent chemotherapy in patients with newly diagnosed sarcoma.
- Compare the tolerance to these regimens by these patients.
- Compare the pharmacokinetics of these regimens in these patients.
- Compare the neutrophil recovery in patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed newly diagnosed sarcoma
- Ewing's sarcoma family of tumors including peripheral
neuroectodermal tumors
- Alveolar rhabdomyosarcoma
- Stage III or IV embryonal rhabdomyosarcoma
- Malignant peripheral nerve sheath tumor with one of the following:
- Unresectable disease
- Incompletely resected with bulk residual disease
- Metastatic disease
- Synovial cell sarcoma
with one of the following:
- Unresectable disease
- Incompletely resected with bulk residual disease
- Metastatic
disease
- No histological evidence of bone marrow infiltration
Prior/Concurrent Therapy:
Biologic therapy: - No other concurrent growth factors (e.g., sargramostim
(GM-CSF), epoetin alfa, or interleukin-11)
Chemotherapy: Endocrine therapy: Radiotherapy: Surgery: - See Disease Characteristics
Patient Characteristics:
Age: - 25 and under at diagnosis
Performance status: Life expectancy: Hematopoietic: - Absolute neutrophil count at least 1,500/mm3
- Hemoglobin at least 9.0 g/dL
- Platelet count at least 100,000/mm3
Hepatic: - Bilirubin less than 2.5 times upper limit of normal
(ULN)
- SGPT less than 5 times ULN
Renal: - Creatinine normal
OR - Creatinine clearance greater than 60 mL/min
Cardiovascular: - Ejection fraction normal by MUGA or echocardiogram
Other: - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and
for 6 months after study therapy
Projected Accrual A total of 34 patients (17 per treatment arm) will be accrued for this study within 2 years. Outline This is a randomized, multicenter study. Patients are randomized to one
of two treatment arms. All patients receive chemotherapy every 3 weeks for a total of 14
courses in the absence of disease progression or unacceptable toxicity.
During courses 1, 2, 5, 9, 11, and 13, patients receive dexrazoxane IV over 15-30 minutes and doxorubicin IV over 15 minutes on days 1 and 2; vincristine IV on day 1 and on days 8 and 15 in courses 1, 2, 9, and 13 only; and cyclophosphamide IV over 1 hour once daily on days 1 and 2. During courses 3, 4, 6, 7, 8, 10, 12, and 14, patients receive etoposide
IV over 1 hour and ifosfamide IV over 1 hour once daily on days 1-5. - Arm I: Patients receive chemotherapy as outlined above and filgrastim
(G-CSF) subcutaneously (SC) daily starting 24 hours after chemotherapy and
continuing until blood counts recover.
- Arm II: Patients receive chemotherapy as in arm I and filgrastim-SD/01
SC as a single dose 24-36 hours after chemotherapy.
Local control may commence after course 5 and may consist of surgery
and/or radiotherapy. Patients are followed monthly for 6 months, every 3 months for 6 months,
every 6 months for 2 years, and then annually for 2 years. Disclaimer The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research | | | Elizabeth Fox, MD, Protocol chair | | | | Trial Sites and Contacts
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U.S.A. |
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Maryland |
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Bethesda |
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| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support |
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| Patient Recruitment | |
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Ohio |
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Cincinnati |
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| Cincinnati Children's Hospital Medical Center |
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| John Perentesis, MD | Ph: | 513-636-6090 | | 800-344-2462 |
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Washington |
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Seattle |
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| Children's Hospital and Regional Medical Center - Seattle |
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| Douglas Hawkins, MD | |
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