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Phase II Chemotherapy with Aclacinomycin in Previously Untreated Patients with Advanced Stage III/IV Soft Tissue Sarcomas
Basic Trial Information
Objectives I. Determine the therapeutic effectiveness, response rate, and duration of response to aclacinomycin-A of previously untreated patients with advanced soft tissue sarcomas. II. Evaluate the incidence of cardiotoxicity and alopecia in these patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Previously untreated patients older than the age of 18 with histologically proven, nonresectable, measurable soft tissue sarcoma of the following histologies: fibrosarcoma, malignant fibrous histiocytoma, malignant giant cell tumor of soft parts, liposarcoma, leiomyosarcoma, rhabdomyosarcoma (mixed, pleomorphic), angiosarcoma, malignant hemangiopericytoma, lymphangiosarcoma, synovial sarcoma, malignant schwannoma, alveolar soft-part sarcoma, malignant granular cell tumor, clear-cell sarcoma of tendon and aponeurosis, epithelioid sarcoma, spindle-cell sarcoma (not further classified), and undifferentiated sarcoma. Patients with bone-only disease are ineligible. The Karnofsky performance status must be at least 50 percent and the estimated survival at least 60 days. Bone marrow, kidney, and liver function must be adequate, and there may be no CNS metastases or a second primary cancer. Patients must not have evidence of uncompensated heart failure or other serious cardiac dysfunction, or uncompensated hypertension. Expected Enrollment 14-25 evaluable patients will be entered. Protocol closed September 1983. Outline Nonrandomized study. Single-agent Chemotherapy. Aclacinomycin-A, ACM-A, NSC-208734.Published Results Bertrand M, Multhauf P, Bartolucci A, et al.: Phase II study of aclarubicin in previously untreated patients with advanced soft tissue sarcoma: a Southeastern Cancer Study Group trial. Cancer Treat Rep 69(6): 725-726, 1985. Trial Lead Organizations Southeastern Cancer Study Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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