A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 (rIL-21) in Subjects With Metastatic Melanoma or Metastatic Renal Cell Carcinoma
This is a phase 1 safety study. Everyone enrolled and eligible will be given rIL-21. The
study has 2 parts, Part A will determine how high a dose of rIl-21 can be safely given to
patients with these types of cancers. Part B will determine if the drug is of any benefit
to patients with these types of cancers. Part A may have up to 7 different dose groups.
Beginning with the lowest dose, 3 patients will be treated and will be watched for side
effects. If the side effects are not severe, the next group of 3 patients will recieve a
higher dose. This cycle is repeated until the highest tolerated dose group is found.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) of rIL-21
Diana Hausman, MD
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|University of Washington/Seattle Cancer Care Alliance||Seattle, Washington 98109|