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| Sponsored by: |
ZymoGenetics |
|---|---|
| Information provided by: | ZymoGenetics |
| ClinicalTrials.gov Identifier: | NCT00095108 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Kidney Neoplasms Metastases |
Drug: Recombinant Human Interleukin-21 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 43 |
| Study Start Date: | May 2004 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Washington | |
| University of Washington/Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| Study Director: | Diana Hausman, MD | ZymoGenetics |
More Information
| Study ID Numbers: | 494C10 |
| Study First Received: | October 29, 2004 |
| Last Updated: | March 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00095108 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Metastatic Melanoma Metastatic Renal Cell Carcinoma |
|
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Renal Cancer Urologic Diseases |
Kidney Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Carcinoma, Renal Cell Neuroepithelioma Nevus Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Neuroendocrine Tumors Melanoma Carcinoma Neuroectodermal Tumors Neoplastic Processes Neoplasms Pathologic Processes |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neoplasm Metastasis Nevi and Melanomas Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
