A Phase I trial of an outpatient regimen of recombinant human interleukin-2 and alpha-2a-interferon in patients with solid tumors

Article Abstract:

Researchers are actively investigating interleukin-2 and interferon as possible treatments for some forms of cancer. Both of these substances are synthesized in the body as a part of the body's normal immune response. However, massive amounts must be administered for anticancer effects, and, in these doses, serious side effects are common. A study was conducted to determine dose ranges appropriate for further investigation. All 17 patients in the study had some form of solid tumor, such as breast cancer or melanoma, which had proved resistant to standard forms of treatment. The dose of alpha-2a-interferon was held constant through the series of treatments, but the dose of interleukin-2 was varied to determine the maximum dose of interleukin-2 that can be tolerated in combination with interferon. The four-week treatment consisted of six million units of interferon per square meter of body area on Monday, Wednesday, and Friday. Every day, Monday through Friday the patients received a two-hour infusion of interleukin-2. For the first week, the interleukin-2 dose was one million units per square meter each day. For the second week, the dose was raised to two million, and to three and four million units for the third and fourth weeks, respectively. It was found that patients could not tolerate the four million unit per square meter daily dose of interleukin-2 in combination with alpha-2a-interferon. Fever and chills and overwhelming fatigue were the most common side effects. The results of this study might be interpreted to indicate that three million units of interleukin-2 is the most appropriate dose to evaluate in future studies. In the present study, one patient with melanoma achieved a partial response. (Consumer Summary produced by Reliance Medical Information, Inc.)

Complications and side effects, Cancer, Dosage and administration, Chemotherapy

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A Phase II trial of interleukin-2 by continuous infusion and interferon by intramuscular injection in patients with renal cell carcinoma

Article Abstract:

Renal cell carcinoma, a form of kidney cancer, has responded poorly to all the chemotherapeutic agents and hormonal treatments that have so far been tested. Recently, the attention of researchers has turned towards substances such as interferon and interleukin-2 for the treatment of renal cell carcinoma. These substances exert powerful effects on the function of immune system cells, and may affect cancer cells directly, as well. The combination of interleukin-2 and interferon was evaluated in 15 patients with advanced renal cell carcinoma. The patients received intravenous infusion of interleukin-2 and intramuscular injection of interferon for four days each week. The protocol was repeated for four weeks. All patients in this study experienced moderate to severe side effects as a result of the treatment, including chills and fever, nausea and vomiting, anorexia, and fatigue. Thirteen of 15 patients experienced tachycardia (racing heart beat), and in 14 cases the patient's blood pressure dropped. However, complete responses to treatment were achieved by two patients, and partial responses by two more. Both patients who achieved complete remission had metastatic cancer; however, they continue to be free of disease at 14 and 24 months of follow-up. These results indicate that the combination of interleukin-2 and interferon shows promise in the treatment of renal cell carcinoma and should be evaluated further. (Consumer Summary produced by Reliance Medical Information, Inc.)

Research, Drug therapy, Combination, Combination drug therapy, Interferon

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A Phase I study of recombinant human interleukin-2 and alpha-interferon-2a in patients with renal cell cancer, colorectal cancer, and malignant melanoma

Article Abstract:

Experiments in several mouse models of human cancer suggest that synergy occurs with the combination of interleukin-2 (IL-2) and alpha-interferon (alpha IFN). That is, the combination of the two agents is more effective than the sum of their individual anticancer activities. A clinical trial was conducted to determine the maximum dose of the combination that could be tolerated by human patients with a variety of different cancers. The toxic effects of fatigue, diarrhea, low blood pressure, fluid retention, and anorexia limited the dose of the combination to 5 million units per meter squared of body area of interleukin-2 per day, and 6 million units per meter squared of alpha interferon per day. One patient suffered a cardiac arrest, which is considered to represent Grade IV toxicity. Less than half the patients experienced Grade III toxicity; 33 percent had non-life-threatening Grade III toxicity, and 13 percent developed life-threatening Grade III complications in the lungs or nervous system. The drug combination was found to have no measurable beneficial effect on melanoma, lymphoma, and colorectal cancer. However, 4 of 18 patients with kidney cell cancer showed a partial response to the combination treatment. (Consumer Summary produced by Reliance Medical Information, Inc.)

Colorectal cancer, Melanoma

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