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

Abstract

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 greater than 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 less than 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.

• Authors: R P Warrell Jr, C J Coonley, D J Straus, C W Young
• Journal: Cancer (Cancer) Vol. 51 Issue 11 Pg. 1982-7 (Jun 01 1983) ISSN: 0008-543X [Print] United States
• PMID: 6839291 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antineoplastic Agents
• Creatinine
• Gallium
• gallium nitrate

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects)
• Bone Marrow (drug effects)
• Creatinine (blood)
• Drug Administration Schedule
• Drug Evaluation
• Gallium (administration & dosage, adverse effects)
• Humans
• Hypocalcemia (chemically induced)
• Infusions, Parenteral
• Kidney Diseases (chemically induced)
• Lung Diseases (chemically induced)
• Lymphoma (drug therapy)
• Middle Aged