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Phase II Study of Aminocamptothecin by 72-Hour Infusion for Advanced Cutaneous T-Cell Lymphoma (Summary Last Modified 03/2001)
Alternate Title Aminocamptothecin in Treating Patients With T-cell Lymphoma
Objectives I. Assess the antitumor activity of aminocamptothecin (9-AC) administered by 72-hour infusion in patients with advanced cutaneous T-cell lymphoma. II. Assess the toxic effects of 9-AC administered on this schedule. Entry Criteria Disease Characteristics: Histologically confirmed, advanced stages IIB/III/IV cutaneous T-cell lymphoma Measurable or evaluable disease required Measurable disease includes: Skin disease evaluated by clinical assessment grid method Lesion measurable on imaging (i.e., CT measurement of lymph nodes) Pure osteolytic lesion Unidimensional lesion for which a normal measurement is available (e.g., mediastinal width on x-ray) Evaluable disease defined as malignant disease evident on physical or radiographic exam but not measurable by ruler or caliper, i.e.: Pelvic masses Confluent multinodular lung metastases Skin metastases CNS metastases eligible if stable for at least 4 weeks following completion of surgery or radiotherapy Prior/Concurrent Therapy: Biologic therapy: Prior biological therapy allowed Chemotherapy: Prior systemic chemotherapy allowed Patients with more than 1 prior regimen analyzed separately At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Prior skin irradiation allowed At least 4 weeks since wide-field radiotherapy Surgery: Fully recovered from prior surgery Other: Prior topical therapy allowed Prior PUVA allowed Patient Characteristics: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No contraindication to indwelling central venous catheter No active infection including HIV No other medical condition that would preclude protocol compliance No pregnant or nursing women Adequate contraception required of fertile patients Expected Enrollment 30A total of 30 patients will be accrued; if no more than 1 response is seen in the first 15 patients, the study will close. Probable duration of study is 18 months. Outline Single-Agent Chemotherapy. Aminocamptothecin, 9-AC, NSC-603071. Trial Lead Organizations Yale Cancer Center
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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