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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077285 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Drug: carboplatin Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: irinotecan hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Phase II Trial Of Irinotecan Plus Carboplatin, And Irinotecan Maintenance Therapy (High-Risk Patients Only), Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma |
Estimated Enrollment: | 61 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed rhabdomyosarcoma (RMS), undifferentiated sarcoma, or ectomesenchymoma, meeting criteria for 1 of the following:
High-risk disease
Intermediate-risk disease
Newly diagnosed
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Leonard H. Wexler, MD 212-639-7990 wexlerl@mskcc.org |
Study Chair: | Leonard H. Wexler, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Leonard H. Wexler ) |
Study ID Numbers: | CDR0000350083, MSKCC-03099 |
Study First Received: | February 10, 2004 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00077285 |
Health Authority: | Unspecified |
previously untreated childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma adult rhabdomyosarcoma stage IV adult soft tissue sarcoma metastatic childhood soft tissue sarcoma |
nonmetastatic childhood soft tissue sarcoma childhood malignant mesenchymoma adult malignant mesenchymoma stage III adult soft tissue sarcoma stage II adult soft tissue sarcoma stage I adult soft tissue sarcoma |
Malignant mesenchymal tumor Irinotecan Vincristine Carboplatin Cyclophosphamide Etoposide phosphate Camptothecin Soft tissue sarcomas |
Doxorubicin Razoxane Neoplasms, Connective and Soft Tissue Ifosfamide Sarcoma Etoposide Rhabdomyosarcoma Isophosphamide mustard |
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myosarcoma Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Cardiovascular Agents Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Chelating Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |