Full Text View
Tabular View
No Study Results Posted
Related Studies
Filgrastim Compared With Filgrastim-SD/01 Following Combination Chemotherapy in Treating Patients With Newly Diagnosed Sarcoma
This study is ongoing, but not recruiting participants.
Study NCT00020137   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 15, 2009   History of Changes

July 11, 2001
July 15, 2009
June 2000
 
Duration of neutropenia
Same as current
Complete list of historical versions of study NCT00020137 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics
  • Differences in CD34 stem cell mobilization
  • Days of febrile neutropenia
  • Days on antibiotics
  • Hospital days
Same as current
 
Filgrastim Compared With Filgrastim-SD/01 Following Combination Chemotherapy in Treating Patients With Newly Diagnosed Sarcoma
A Randomized Trial of SD/01-Filgrastim VS. Filgrastim in Newly Diagnosed Children and Young Adults With Sarcoma Treated With Dose-Intensive Chemotherapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim or filgrastim-SD/01 may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim is more effective than filgrastim-SD/01 is in helping patients recover from chemotherapy.

PURPOSE: This randomized phase III trial is studying filgrastim to see how well it works compared to filgrastim-SD/01 following combination chemotherapy in treating patients with newly diagnosed sarcoma.

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.

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.

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

Phase III
Interventional
Supportive Care, Randomized, Active Control
  • Cardiac Toxicity
  • Neutropenia
  • Sarcoma
  • Biological: filgrastim
  • Biological: pegfilgrastim
  • Drug: cyclophosphamide
  • Drug: dexrazoxane hydrochloride
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: ifosfamide
  • Drug: vincristine sulfate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
34
 
 

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

PATIENT CHARACTERISTICS:

Age:

  • 25 and under at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 9.0 g/dL
  • Platelet count at least 100,000/mm^3

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

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
Both
up to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020137
 
CDR0000067774, NCI-00-C-0092, AMGEN-20000124
National Cancer Institute (NCI)
 
Study Chair: Crystal Mackall, MD NCI - Pediatric Oncology Branch
National Cancer Institute (NCI)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP