Trial | NCT00095108  Report issue

Title

Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    denenicokin ...

  • Study Participants

    43
This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.
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.
Study Started
May 31
2004
Primary Completion
Jan 31
2007
Study Completion
Jan 31
2007
Last Update
Mar 09
2009
Estimate

Drug Recombinant Human Interleukin-21

Criteria 

Inclusion Criteria:

18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer
ECOG status of 0 or 1
Patients must have adequate liver, kidney and bone marrow function

Exclusion Criteria:

Known ocular melanoma
Suspected or confirmed brain metastases
Patient cannot have had a bone marrow transplant
No Results Posted