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Phase II Chemotherapy with Spirogermanium in Adults with Refractory Hodgkin's and non-Hodgkin's Lymphoma
Basic Trial Information
Objectives I. Determine the therapeutic efficacy, in terms of response rate and duration of response, of spirogermanium in adult patients with advanced Hodgkin's disease and non-Hodgkin's lymphomas refractory to prior chemotherapy with or without radiotherapy. II. Determine the toxicity associated with spirogermanium administration in these patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Adult patients under the age of 75 years with histologically proven Hodgkin's disease or non-Hodgkin's lymphoma (excluding CLL and DLWD non-Hodgkin's lymphoma in leukemic phase). Disease must be progressive and resistant to conventional chemotherapy. There must be at least one clinically and/or radiologically measurable disease parameter; prior radiotherapy to a measurable lesion is acceptable provided that radiotherapy was not administered during the 3 weeks prior to entry and that there has been clearly demonstrated evidence of progression. There may have been no cytotoxic chemotherapy or radiotherapy within 3 weeks of admission (4 weeks for nitrosoureas). The expected survival must be at least 6 weeks and the WHO performance status 2 or less. Hematopoietic, hepatic, and renal function must be adequate. Per revision, protocol specifies no upper age limit for entry; patients must be more than 15 years old. Expected Enrollment Initially 14 patients will be entered into each group (Hodgkin's disease and low, intermediate, and high grade non-Hodgkin's lymphoma); if one or more responses are noted, additional patients will be entered. Outline Nonrandomized study. Single-agent Chemotherapy. Spirogermanium, SPG, NSC-192965. Trial Lead Organizations European Organization for Research and Treatment of Cancer
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. Back to Top |
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