|
||||||||||||||||||||||
![]() |
|
|
|
![]() |
Phase I Study of Cyclopentenylcytosine in Pediatric Patients with Advanced Neoplastic Disease (Summary Last Modified 11/92)
Basic Trial Information
Objectives I. Determine the MTD and dose-limiting toxicity of cyclopentenylcytosine (CPE-C) administered as a 24-hour infusion using a pharmacologically guided dose escalation scheme in children with refractory cancer. II. Determine the incidence and severity of other toxicities of CPE-C as administered in these patients. III. Determine a safe and tolerable dose for 24-hour infusion to be used in Phase II trials. IV. Determine the pharmacokinetics of a 24-hour infusion of CPE-C in children. Entry Criteria Disease Characteristics: Histologically proven malignancy that is refractory to conventional therapy Prior/Concurrent Therapy: Biologic therapy: Recovery from toxicity of prior immunotherapy required Chemotherapy: At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) Recovery from toxicity of prior chemotherapy required Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy (e.g., hemipelvic or craniospinal) No prior total-body irradiation in conjunction with bone marrow transplantation Recovery from toxicity of prior radiotherapy required Surgery: Not specified Patient Characteristics: Age: 1 to 25 Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: AGC greater than 1,500 Platelets greater than 100,000 Hb greater than 9 g/dl Granulocytopenia, anemia, or thrombocytopenia secondary to bone marrow involvement with leukemia is allowed Hepatic: Bilirubin less than 2.0 mg/dl SGPT less than 2 x normal Renal: Creatinine less than 1.5 mg/dl Other: No significant systemic illness (e.g., infection) No pregnant or nursing women Expected Enrollment Approximately 15-20 patients will be entered over 1 year. At least 3 patients must be evaluable for hematologic toxicity in each cohort (at least 6 patients in expanded cohorts). Outline Nonrandomized study. Single-agent Chemotherapy. Cyclopentenylcytosine, CPE-C, NSC-375575. Trial Lead Organizations NCI - Center for Cancer Research
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. |
![]() |
![]() |
![]() |
![]() |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
![]() A Service of the National Cancer Institute |
![]() |
![]() |