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Treatment of patients with advanced malignant lymphoma using gallium nitrate administered as a seven‐day continuous infusion

Previous trials of gallium nitrate (NSC‐15200) showed that bolus administration produced dose‐limiting nephrotoxicity without substantial antitumor activity. As an effort to increase the therapeutic index of this compound and to establish a satisfactory out‐patient schedule, the authors evaluated the effects of gallium nitrate administered as a continuous infusion in patients with advanced malignant lymphoma. In an initial Phase I trial, four dose levels which ranged from 200 to 400 mg/m2/day in 27 patients were studied. Nausea which impaired oral hydration was found to be dose‐limiting. A dose of 300 mg/ m2/day was chosen for extended Phase II evaluation and 37 additional patients were entered into the study at that dose level. Overall, 16 of 47 patients (34%) who had bi‐dimensionally measurable parameters of disease achieved major antitumor responses (six of 15 with diffuse “histiocytic” lymphoma, five of ten with diffuse poorly‐differentiated lymphocytic lymphoma, two of five with nodular poorly‐differentiated lymphocytic lymphoma, and three of 17 with Hodgkin's disease). The median duration of response was 2.5 months. Only 8% of patients who received 300 mg/m2/day developed an increase in serum creatinine concentration >1.1 mg/dl over baseline values. Hypocalcemia occurred in two‐thirds of patients. Other toxic effects, including paresthesiae, diarrhea, and hearing loss, were noted in <5% of patients. There was minimal myelosuppression. The authors conclude that gallium nitrate administered as a continuous infusion for seven days at 300 mg/m2/day is well‐tolerated and effective treatment for patients with advanced malignant lymphoma. Outpatient administration using portable infusion pumps is safe and practical. Further evaluation of the drug administered as a constant infusion is indicated in patients with other neoplastic diseases.