Phase II study of subcutaneous rHu-interleukin-2 and rHu-interferon alpha-2a in previously treated patients with multiple myeloma.
BACKGROUND
Several studies have shown that interferon alpha as a single agent produces responses in multiple myeloma patients, and may produces responses in multiple myeloma of interleukin-2 (rHu-IL-2) in multiple myeloma models indicate that rHu-IL-2 may have a therapeutic effect. In this phase II clinical trial, we combined rHu-interferon alpha-2a (rHu-IFN-2a) and rHu-IL-2, to assess the feasibility, toxicity and response rate when this treatment was given as subcutaneous injections to previously treated patients with relapsed or refractory multiple myeloma.


METHODS
Seventeen patients with measurable serum M protein or urine paraprotein were entered on the study. Three patients were refractory to first line treatment; fourteen had relapsed following response to prior treatment. rHu-IFN alpha-2a was given three times per week continuously. rHu-IL-2 was given three times per week for 6 weeks followed by a 2-week break from treatment. Patients were assessed for response and toxicity at 4-week intervals.


RESULTS
All patients were eligible and evaluable for toxicity; two patients were invaluable for response because they did not complete 4 weeks of treatment. All response-evaluable patients had a best objective response of stable disease which lasted a median of 22 weeks and was maintained for over one year in 5 patients. Toxicity was tolerable and was typical of rHu-IL-2 and rHu-IFN alpha-2a; fever, chills or rigors and lethargy were nearly universal; local toxicity at the injection site, headache, anorexia, nausea and vomiting were also common.


CONCLUSIONS
No objective responses in serum M protein or urine paraprotein levels were noted thus we do not recommend further study of this combination in myeloma.
Belch
A R
AR
Cross Cancer Institute, Edmonton, Alberta, Canada.
Eisenhauer
E A
EA
Muldal
A
A
Browman
G
G
Klasa
R
R
Osterwalder
B
B
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002170:Canada; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use
D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins