title: Phase II trial of low dose gamma-interferon in metastatic renal cell carcinoma.
abstract: We conducted a phase II trial to confirm the activity of fixed, low dose gamma-interferon in metastatic renal cell carcinoma. A total of 35 patients with metastatic renal cell carcinoma, who had not received prior immunotherapy and who had a Zubrod performance status of 2 or less, was enrolled in this study. Primary tumors were controlled by nephrectomy or embolization before treatment began. gamma-Interferon was administered weekly as a subcutaneous injection at a fixed dose of 100 micrograms. Toxic effects were limited to low grade fever, chills and myalgias within 24 hours of injection. There were no incidences of grade 3 or 4 toxicity. Responses could be evaluated in 34 patients. There were 1 complete and 4 partial responses, for an objective response rate of 15% (95% confidence interval 5 to 32%). Durations of response to date are 21+, 17+, 13+, 9 and 2 months. We conclude that gamma-interferon is an active agent for metastatic renal cell carcinoma when administered according to this dose and schedule. The response rate compares favorably with those of alpha-interferon and interleukin-2, and toxicity is minimal. gamma-Interferon has excellent potential for use in combination with other biological or chemotherapeutic agents and in the adjuvant setting.
authors.affiliation: Department of Genitourinary Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030.
authors.forename: J A
authors.initials: JA
authors.lastname: Ellerhorst
authors.forename: R G
authors.initials: RG
authors.lastname: Kilbourn
authors.forename: R J
authors.initials: RJ
authors.lastname: Amato
authors.forename: A A
authors.initials: AA
authors.lastname: Zukiwski
authors.forename: E
authors.initials: E
authors.lastname: Jones
authors.forename: C J
authors.initials: CJ
authors.lastname: Logothetis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007371:Interferon-gamma / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis
chemical_list: D007371:Interferon-gamma