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| Sponsored by: |
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 |
| Estimated Enrollment: | 34 |
| Study Start Date: | June 2000 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed sarcoma
Malignant peripheral nerve sheath tumor with one of the following:
Synovial cell sarcoma with one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and 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 | |
| Study Chair: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000067774, NCI-00-C-0092G, AMGEN-20000124 |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020137 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neuroectodermal Tumors, Primitive Immunologic Factors Leukocyte Disorders Cyclophosphamide Etoposide phosphate Granulocytopenia Razoxane Sarcoma, Synovial Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Soft Tissue Sarcomas Neuroepithelioma Synovial Sarcoma Ewing's Family of Tumors |
Alkylating Agents Etoposide Rhabdomyosarcoma Hematologic Diseases Agranulocytosis Vincristine Rhabdomyosarcoma, Childhood Antimitotic Agents Cardiovascular Agents Immunosuppressive Agents Ewing's Sarcoma Doxorubicin Neutropenia Neuroectodermal Tumors Malignant Mesenchymal Tumor |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukocyte Disorders Cyclophosphamide Antibiotics, Antineoplastic Razoxane Neoplasms, Connective and Soft Tissue Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Hematologic Diseases Mitosis Modulators Agranulocytosis |
Vincristine Antimitotic Agents Cardiovascular Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neutropenia Ifosfamide Neoplasms Tubulin Modulators Sarcoma Myeloablative Agonists Chelating Agents Antineoplastic Agents, Alkylating Leukopenia |
