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Sponsors and Collaborators: |
Sarcoma Alliance for Research through Collaboration National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00304083 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with stage III or stage IV malignant peripheral nerve sheath tumors.
Condition | Intervention | Phase |
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Neurofibromatosis Type 1 (nf1) Sarcoma |
Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: ifosfamide Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Nerve Sheath Tumors |
Estimated Enrollment: | 74 |
Study Start Date: | December 2005 |
Arms | Assigned Interventions |
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Chemotherapy and local control by radiotherapy and surgery: Experimental
Patients receive doxorubicin hydrochloride and ifosfamide (IA) chemotherapy. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity. Patients then receive etoposide and ifosfamide (IE) chemotherapy. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim (G-CSF) subcutaneously (SC) after each chemotherapy course. After recovery from chemotherapy, patients undergo radiotherapy and receive 2 more courses of IE during radiotherapy followed by 2 more courses of IA after completion of radiotherapy. Some patients may then undergo surgery.
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Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: filgrastim
Given subcutaneously
Drug: ifosfamide
Given IV
Procedure: conventional surgery
Patients undergo surgery
Procedure: radiation therapy
Patients undergo radiotherapy
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Chemotherapy and local control by surgery: Experimental
Patients receive 2 courses of IA followed by 2 courses of IE as above. After recovery from chemotherapy, patients undergo surgery. After recovery from surgery, patients receive 2 more courses of IA followed by 2 more courses of IE in the absence of disease progression or unacceptable toxicity.
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Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: ifosfamide
Given IV
Procedure: conventional surgery
Patients undergo surgery
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to type of malignant peripheral nerve sheath tumor (MPNST) (sporadic MPNST vs neurofibromatosis type 1 [NF1]-associated MPNST). Patients receive 1 of 2 treatment regimens depending on the location of the MPNST and tumor response to chemotherapy.
After recovery from chemotherapy, patients undergo radiotherapy and receive 2 more courses of IE during radiotherapy followed by 2 more courses of IA after completion of radiotherapy. Some patients may then undergo surgery.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed sporadic or neurofibromatosis type 1 (NF1)-associated high-grade malignant peripheral nerve sheath tumors (MPNSTs)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No other concurrent growth factors (e.g., sargramostim [GM-CSF] or interleukin-11)
United States, Illinois | |
Children's Memorial Hospital - Chicago | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: Contact Person 773-880-4000 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202-5289 | |
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Contact Person 319-356-7360 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109-0942 | |
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
United States, Minnesota | |
Children's Hospitals and Clinics of Minnesota - St. Paul | Recruiting |
St. Paul, Minnesota, United States, 55102 | |
Contact: Christopher Moertel, MD 651-220-6732 chris.moertel@childrensmn.org | |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
Minneapolis, Minnesota, United States, 55404 | |
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193 | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
United States, Missouri | |
St. Louis Children's Hospital | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Contact Person 314-454-6018 | |
United States, North Carolina | |
Carolinas Hematology-Oncology Associates | Recruiting |
Charlotte, North Carolina, United States, 28203 | |
Contact: Michael B. Livingston, MD 704-446-9046 michael.livingston@carolinashealthcare.org | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-0161 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Contact Person 215-590-1000 | |
Joan Karnell Cancer Center at Pennsylvania Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19106 | |
Contact: Arthur P. Staddon, MD 215-829-6088 staddona@pahosp.com | |
United States, Texas | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030-2399 | |
Contact: Alberto S. Pappo, MD 832-822-4200 |
Investigator: | Denise Reinke, MS, NP | Sarcoma Alliance for Research through Collaboration |
Principal Investigator: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000465364, SARC-006, NCI-06-C-0043, NCI-P6452, UMN-2007CG077 |
Study First Received: | March 15, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00304083 |
Health Authority: | Unspecified |
adult neurofibrosarcoma childhood neurofibrosarcoma metastatic childhood soft tissue sarcoma |
nonmetastatic childhood soft tissue sarcoma stage IV adult soft tissue sarcoma neurofibromatosis type 1 (NF1) |
Malignant mesenchymal tumor Neurodegenerative Diseases Etoposide phosphate Doxorubicin Neurofibromatosis type 1 Soft tissue sarcomas Neurofibromatosis 1 Neoplasms, Connective and Soft Tissue Ifosfamide Neoplastic Syndromes, Hereditary Heredodegenerative Disorders, Nervous System Nerve sheath neoplasm |
Neurofibroma Genetic Diseases, Inborn Neuromuscular Diseases Peripheral Nervous System Diseases Sarcoma Neurofibromatoses Peripheral Nervous System Neoplasms Etoposide Nerve Sheath Neoplasms Nervous System Neoplasms Isophosphamide mustard Neurocutaneous Syndromes |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Nervous System Diseases |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Antibiotics, Antineoplastic Alkylating Agents Pharmacologic Actions |