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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00544778 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Giving combination chemotherapy together with dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with dexrazoxane followed by surgery and radiation therapy works in treating patients with advanced soft tissue sarcoma or recurrent bone sarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Biological: filgrastim Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: irinotecan hydrochloride Genetic: protein expression analysis Other: immunoenzyme technique Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Neoadjuvant Dose-Dense Doxorubicin, Ifosfamide, and Irinotecan (CPT-11) for Advanced Soft Tissue and Recurrent Bone Sarcomas |
Estimated Enrollment: | 44 |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: Patients are stratified by type of sarcoma (soft tissue vs bone), prior treatment (untreated vs treated), and presence of metastases (yes vs no).
Patients then undergo standard surgery and radiotherapy.
Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for MDR (multidrug resistance gene) protein expression via immunoperoxidase staining.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then once a year thereafter.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Primary soft tissue sarcoma at high-risk* for recurrence, meeting any of the following criteria:
Recurrent bone sarcoma (e.g., osteogenic sarcoma, Ewing sarcoma, or peripheral neuroectodermal tumor)
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000566381, CHNMC-00050 |
Study First Received: | October 13, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00544778 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma metastatic osteosarcoma |
recurrent osteosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor Ewing sarcoma of bone |
Neuroectodermal Tumors, Primitive Irinotecan Razoxane Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Soft Tissue Sarcomas Sarcoma, Ewing's Osteogenic Sarcoma Neuroepithelioma Ewing's Family of Tumors Alkylating Agents Adjuvants, Immunologic Osteosarcoma Cardiovascular Agents Ewing's Sarcoma |
Recurrence Doxorubicin Camptothecin Neuroectodermal Tumors Malignant Mesenchymal Tumor Ifosfamide Mechlorethamine Sarcoma Peripheral Neuroectodermal Tumor Chelating Agents Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral Isophosphamide mustard |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Enzyme Inhibitors Cardiovascular Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Camptothecin Razoxane |
Neoplasms, Connective and Soft Tissue Neoplasms Ifosfamide Therapeutic Uses Sarcoma Chelating Agents Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Isophosphamide mustard |