Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Filgrastim Compared With Filgrastim-SD/01 Following Combination Chemotherapy in Treating Patients With Newly Diagnosed Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 25 and under at diagnosis NCI NCI-00-C-0092G AMGEN-20000124, NCT00020137

Objectives

1. Compare the toxicity of filgrastim-SD/01 vs filgrastim (G-CSF) administered with concurrent chemotherapy in patients with newly diagnosed sarcoma.
2. Compare the tolerance to these regimens by these patients.
3. Compare the pharmacokinetics of these regimens in these patients.
4. 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:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 25 and under at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

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

Expected Enrollment

A total of 34 patients (17 per treatment arm) will be accrued for this study within 2 years.

Outcomes

Duration of neutropenia

Pharmacokinetics
Differences in CD34 stem cell mobilization
Days of febrile neutropenia
Days on antibiotics
Hospital days

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Elizabeth Fox, MD, Protocol chair		Ph: 301-402-6641 Email: foxb@mail.nih.gov

Registry Information
Official Title		A Randomized Trial of SD/01-Filgrastim VS. Filgrastim in Newly Diagnosed Children and Young Adults with Sarcoma Treated with Dose-Intensive Chemotherapy
Trial Start Date		2000-06-14
Registered in ClinicalTrials.gov		NCT00020137
Date Submitted to PDQ		2000-03-08
Information Last Verified		2006-08-15