A phase I study of prolonged continuous infusion of low dose recombinant interleukin-2 in melanoma and renal cell cancer. Part I: clinical aspects

1992

Continuous Low Dose Interleukin-2 for Melanoma and Renal Cell Cancer

Sample size: 22 publication Evidence: moderate

Author Information

Author(s): L.T. Vlasveld, E.M. Rankin, A. Hekman, S. Rodenhuis, J.H. Beijnen, A.M. Hilton, A.C. Dubbelman, F.A. Vyth-Dreese, C.J.M. Melief

Primary Institution: The Netherlands Cancer Institute

The clinical and immunological effects of prolonged continuous exposure to recombinant interleukin-2 (rIL-2) are unknown.

The study found that continuous self-administration of rIL-2 is feasible and can lead to a partial remission in some patients.

Twenty-two patients entered the study, with 13 having melanoma and 9 with renal cell cancer.
The maximum tolerated dose was found to be 6 x 106 IU m-2 24 h-1.
Thirteen patients were treated for more than 6 weeks and were evaluable for tumor response.
A partial remission occurred in a patient with melanoma at a dose of 1.8 x 106 IU rIL-2 m-2 24 h-1.
Constitutional symptoms were noted, including fatigue and fever, particularly at higher doses.
55% of patients experienced infections related to the central venous access.
Toxicity peaked at 3 weeks and resolved thereafter despite continued treatment.
Immunological effects included increased natural killer cell activity.

Doctors tested a new way to give a medicine called interleukin-2 to help people with certain types of cancer, and it worked for some patients.

Patients received continuous low dose infusion of rIL-2 via central venous access on an out-patient basis.

Potential bias due to the lack of a control group and the subjective nature of some reported outcomes.

The study was limited by the small sample size and the short duration of treatment for some patients.

Patients were aged 26-66 years, with a median age of 51, and included 12 males and 10 females.

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