Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003664
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Biological Therapy In Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed Surgically
Sponsor:
Cancer Biotherapy Research Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Combination Chemobiotherapy With Gemcitabine 5-Fluorouracil Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer A Phase II Study
Status:
UNKNOWN
Status Verified Date:
2000-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Interleukin-2 may stimulate a persons white blood cells to kill kidney cancer cells Interferon alfa may interfere with the growth of cancer cells Combining chemotherapy with biological therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and biological therapy in treating patients with kidney cancer that is metastatic or cannot be removed surgically
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and biological therapy in treating patients with kidney cancer that is metastatic or cannot be removed surgically
Detailed Description:
OBJECTIVES I Determine the toxic effects of interferon alfa interleukin-2 gemcitabine and fluorouracil in patients with metastatic or unresectable renal cell cancer II Evaluate the feasibility and possible therapeutic anticancer efficacy of this therapy in these patients III Determine the duration of response survival and improvement of quality of life in these patients
OUTLINE Patients receive fluorouracil IV on days 1 8 15 and 22 followed by gemcitabine IV over 30 minutes on days 29 36 43 and 50 Interferon alfa is administered subcutaneously 3 times weekly beginning on day 1 Beginning on day 2 interleukin-2 is administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic effects and disease progression Following chemobiotherapy maintenance therapy is administered to patients with stable or responding disease Patients receive subcutaneous interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or for a maximum of 1 year A quality of life assessment is completed weekly Patients are followed until death
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 18-24 months
OUTLINE Patients receive fluorouracil IV on days 1 8 15 and 22 followed by gemcitabine IV over 30 minutes on days 29 36 43 and 50 Interferon alfa is administered subcutaneously 3 times weekly beginning on day 1 Beginning on day 2 interleukin-2 is administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic effects and disease progression Following chemobiotherapy maintenance therapy is administered to patients with stable or responding disease Patients receive subcutaneous interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or for a maximum of 1 year A quality of life assessment is completed weekly Patients are followed until death
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| CBRG-9808 | None | None | None |
| NCI-V98-1493 | None | None | None |