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Phase I Study of CI-958 (a Synthetic Intercalating Agent) for Recurrent Pediatric Solid Tumors and Lymphomas (Summary Last Modified 05/2000)
Alternate Title CI-958 in Treating Children With Recurrent Solid Tumors and Lymphomas
Objectives I. Estimate the maximum tolerated dose of the synthetic intercalating agent CI-958 given as a 2-hour infusion every 3 weeks to children and adolescents with recurrent solid tumors and lymphomas. II. Assess the toxicities of CI-958 on this schedule. III. Assess the antitumor activity of CI-958 within the confines of a Phase I study. Entry Criteria Disease Characteristics: Histologically confirmed solid tumor or lymphoma refractory to conventional therapy and higher priority treatment No bone marrow involvement with tumor Aspiration/biopsy required if high risk of metastasis, e.g., for: Ewing's sarcoma Neuroblastoma Rhabdomyosarcoma Retinoblastoma Peripheral neuroectodermal tumor Lymphoma No brain metastases No primary CNS tumor Prior/Concurrent Therapy: Recovered from prior therapy Biologic therapy: Not specified Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Not specified Radiotherapy: No radiotherapy to more than 50% of the bone marrow No total-body irradiation No total-pelvic irradiation No craniospinal irradiation Surgery: Not specified Other: At least 3 months since bone marrow transplantation Patient Characteristics: Age: 21 and under Performance status: 0-2 Life expectancy: At least 2 months Hematopoietic: ANC at least 1,000 Platelets at least 100,000 (transfusion independent) Hb at least 10 g/dl (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 x ULN SGOT or SGPT less than 2.5 x ULN Renal: Creatinine no greater than 1.5 x ULN Creatinine clearance or radioisotope GFR at least 70 ml/min/1.73 sqm Cardiovascular: Shortening fraction at least 27% by echocardiogram OR LVEF greater than 50% by echocardiogram or MUGA Neurologic: No requirement for anticonvulsant therapy No CNS toxicity greater than grade 2 Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 7 days prior to registration Expected Enrollment Up to 21 evaluable patients will be studied over 24 months in this multicenter trial. Outline Single-Agent Chemotherapy. CI-958, NSC-635371 (a synthetic intercalating agent). Trial Lead Organizations Children's Cancer 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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