Evaluation of M40403 for the Prevention of Dose Limiting Toxicities of High Dose IL-2
Status:
Suspended
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The clinical use of IL-2 is currently limited by development of dose-dependent hypotension
(systolic blood pressure (SBP) < 90 mm Hg). The overall outcome is constant across sites with
20-50% of the patients requiring ICU management because of unresponsive hypotension and
hyporeactivity (loss of response to vasoconstrictors). Because of the dose-limiting side
effects, the duration of IL-2 dosing is frequently curtailed. Thus, hemodynamic toxicities
have limited the usefulness of IL-2 therapy. M40403 has prevented both the hypotension and
hyporeactivity associated with IL-2 treatment in preclinical studies. This trial will study
the safety and efficacy of M40403 in the prevention or reduction of hypotension in patients
receiving IL-2 therapy.