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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 1
18 Years
N/A
Not Enrolling
Both
Melanoma, Kidney Neoplasms, Metastases

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of rIL-21

Principal Investigator

Diana Hausman, MD

Investigator Role:

Study Director

Investigator Affiliation:

ZymoGenetics

Authority:

United States: Food and Drug Administration

Study ID:

494C10

NCT ID:

NCT00095108

Start Date:

May 2004

Completion Date:

January 2007

Related Keywords:

  • Melanoma
  • Kidney Neoplasms
  • Metastases
  • Metastatic Melanoma
  • Metastatic Renal Cell Carcinoma
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma
  • Neoplasm Metastasis

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
University of Washington/Seattle Cancer Care Alliance Seattle, Washington  98109