Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003091
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
1999-11-01
Brief Title:
High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2
Status:
COMPLETED
Status Verified Date:
2011-05
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 Interferon alfa may interfere with the growth of cancer cells Interleukin-2 may stimulate a persons white blood cells to kill kidney cancer or melanoma cells
PURPOSE Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer or melanoma
PURPOSE Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer or melanoma
Detailed Description:
OBJECTIVES I Determine the safety efficacy and antitumor activity of high dose interferon alfa-2b and interleukin-2 in patients with metastatic renal cell carcinoma or melanoma II Determine the toxic effects of interferon alfa-2b and interleukin-2 in these patients
OUTLINE This is an open label study Patients receive subcutaneous interferon alfa-2b on days 1-4 Patients are hospitalized and receive bolus infusions of interleukin-2 IL-2 followed by a continuous infusion on days 5-7 Patients are observed at least 12 hours following IL-2 treatment Treatment is repeated every 4 weeks until disease progression or up to a maximum of six cycles Patients are followed every 2 months for one year then for survival
PROJECTED ACCRUAL If at least 1 response is seen in the first 14 patients in each group a maximum of 40 patients per group will be accrued
OUTLINE This is an open label study Patients receive subcutaneous interferon alfa-2b on days 1-4 Patients are hospitalized and receive bolus infusions of interleukin-2 IL-2 followed by a continuous infusion on days 5-7 Patients are observed at least 12 hours following IL-2 treatment Treatment is repeated every 4 weeks until disease progression or up to a maximum of six cycles Patients are followed every 2 months for one year then for survival
PROJECTED ACCRUAL If at least 1 response is seen in the first 14 patients in each group a maximum of 40 patients per group will be accrued
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 |
|---|---|---|---|
| NCI-V97-1346 | None | None | None |
| CBRG-9509 | None | None | None |
| NBSG-9509 | None | None | None |