Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276835
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2006-01-12
Brief Title:
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Interleukin-2 may stimulate the white blood cells including natural killer cells to kill melanoma or kidney cancer cells Giving genistein together with interleukin-2 may kill more tumor cells
PURPOSE This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer
PURPOSE This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer
Detailed Description:
OBJECTIVES
Primary
Measure the differences in peak and duration of the expansion of circulating CD4-positive CD8-positive and CD4- CD25- and CD56-positive cells dim and bright at different time points during therapy with interleukin-2 IL-2 alone and plus genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma
Secondary
Evaluate the differences in peripheral blood mononuclear cell gene expression following high-dose IL-2 with and without genistein and compare to baseline
Determine the overall response rate partial and complete in patients treated with these regimens
Determine the safety and toxic effects of these regimens in these patients
Determine the time to progression in patients treated with these regimens
OUTLINE This is a pilot study
Patients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and 3 times daily on days 2-5 and 16-19 Patients also receive oral genistein twice daily on days 10-19
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Primary
Measure the differences in peak and duration of the expansion of circulating CD4-positive CD8-positive and CD4- CD25- and CD56-positive cells dim and bright at different time points during therapy with interleukin-2 IL-2 alone and plus genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma
Secondary
Evaluate the differences in peripheral blood mononuclear cell gene expression following high-dose IL-2 with and without genistein and compare to baseline
Determine the overall response rate partial and complete in patients treated with these regimens
Determine the safety and toxic effects of these regimens in these patients
Determine the time to progression in patients treated with these regimens
OUTLINE This is a pilot study
Patients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and 3 times daily on days 2-5 and 16-19 Patients also receive oral genistein twice daily on days 10-19
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-IRB-0310-083 | None | None | None |
| NU-04V1 | None | None | None |
| CHIR-NU-04V1 | None | None | None |