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Phase I/II Chemotherapy with 4'-Deoxydoxorubicin Hydrochloride in Children with Malignant Solid Tumors (last Modified 11/87)
Basic Trial Information
Objectives I. Determine the toxic effects of various dosages of 4'-deoxydoxorubicin in pediatric patients with drug-resistant malignant solid tumors. II. Determine the maximum tolerated dose of 4'-deoxydoxorubicin in a Phase I trial for patients with solid tumors, and extend this information toward the completion of a Phase II trial. III. Note the antitumor benefits that may follow the administration of various dosages of 4'-deoxydoxorubicin. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Pediatric patients with an established tissue or marrow diagnosis of drug resistant malignant solid tumors. Measurable indicators of disease activity are not required for the Phase I portion, but may include mass lesions, bone lesions, or infiltration of the bone marrow; measurable indicators are required for the Phase II portion of the study. Patients may not have received chemotherapy within 2 weeks of entry, or they must have recovered from the toxic effects of prior radiotherapy or chemotherapy prior to entry. Prior therapy with greater than 450 mg/sqm of 4'-deoxydoxorubicin excludes. A life expectancy of at least 8 weeks and adequate bone marrow (except in patients with thrombocytopenia or leukopenia secondary to neuroblastoma or other solid tumors with bone marrow infiltration), renal, and hepatic function are required; patients with renal or hepatic function abnormalities may be eligible for the Phase II portion if pharmacokinetics are to be studied. There must be clinical, radiographic, electrocardiographic, MUGA, and echocardiographic evidence of normal cardiac function. Expected Enrollment At least 3 patients will be treated at each dosage level. Outline Nonrandomized study. Single-agent Chemotherapy. 4'-Deoxydoxorubicin, DxDx, NSC-267469. Trial Lead Organizations St. Jude Children's Research Hospital
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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