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

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020137

Purpose

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.

Condition	Intervention	Phase
Cardiac Toxicity Neutropenia Sarcoma	Biological: filgrastim Biological: pegfilgrastim Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Cyclophosphamide Vincristine Razoxane Doxorubicin Dexrazoxane Doxorubicin hydrochloride Etoposide Myocet Etoposide phosphate Filgrastim Dexrazoxane hydrochloride Pegfilgrastim Vincristine sulfate Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Duration of neutropenia

Secondary Outcome Measures:

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

Estimated Enrollment:	34
Study Start Date:	June 2000

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020137

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Crystal Mackall, MD

NCI - Pediatric Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067774, NCI-00-C-0092, AMGEN-20000124
Study First Received:	July 11, 2001
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00020137 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cardiac toxicity
neutropenia
adult synovial sarcoma
stage III adult soft tissue sarcoma
adult rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
nonmetastatic childhood soft tissue sarcoma

metastatic childhood soft tissue sarcoma
previously untreated childhood rhabdomyosarcoma
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
adult neurofibrosarcoma
childhood neurofibrosarcoma
childhood synovial sarcoma

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Leukocyte Disorders
Cyclophosphamide
Antibiotics, Antineoplastic
Razoxane
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Alkylating Agents
Etoposide

Neoplasms by Histologic Type
Hematologic Diseases
Mitosis Modulators
Agranulocytosis
Vincristine
Antimitotic Agents
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions
Doxorubicin
Neuroectodermal Tumors
Neutropenia
Neoplasms
Ifosfamide
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2009