Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003585
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
1999-11-01
Brief Title:
Biological Therapy Plus Chemotherapy in Treating Patients With Metastatic or Recurrent Kidney Cancer
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
A Phase III Pilot Study of a Novel Four Drug Regimen for the Treatment of Advanced Renal Cell Carcinoma FUNIL-cRA
Status:
COMPLETED
Status Verified Date:
2013-12
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining biological therapy with chemotherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of biological therapy plus chemotherapy in treating patients with metastatic or recurrent kidney cancer
PURPOSE Phase III trial to study the effectiveness of biological therapy plus chemotherapy in treating patients with metastatic or recurrent kidney cancer
Detailed Description:
OBJECTIVES I Evaluate the toxic effects patient tolerance and practicality of administering interferon alfa-2b fluorouracil interleukin-2 and isotretinoin FUNIL-cRa in patients with metastatic andor recurrent renal cell carcinoma II Obtain a pilot indication of responsiveness of these patients to this regimen III Evaluate the measurement of tumor thymidylate synthetase as a prediction of response of these patients to this and other fluorouracil based regimens
OUTLINE Patients are stratified by performance status 0 vs 1 nephrectomy yes vs no site of disease pulmonary or lymph node metastases only vs other disease site radiotherapy yes vs no and prior adjuvant biologic or hormone therapy yes vs no Patients receive intravenous fluorouracil daily for 14 days and subcutaneous interferon alfa-2b 3 times a week for 6 weeks Beginning on day 15 patients receive intravenous interleukin-2 5 days a week and oral isotretinoin 2 times a day for 4 weeks Treatment courses are 6 weeks followed by a 2 week rest period Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with partial or complete response may undergo surgical resection Patients are followed every 2 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 35 patients will be accrued to this study
OUTLINE Patients are stratified by performance status 0 vs 1 nephrectomy yes vs no site of disease pulmonary or lymph node metastases only vs other disease site radiotherapy yes vs no and prior adjuvant biologic or hormone therapy yes vs no Patients receive intravenous fluorouracil daily for 14 days and subcutaneous interferon alfa-2b 3 times a week for 6 weeks Beginning on day 15 patients receive intravenous interleukin-2 5 days a week and oral isotretinoin 2 times a day for 4 weeks Treatment courses are 6 weeks followed by a 2 week rest period Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with partial or complete response may undergo surgical resection Patients are followed every 2 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 35 patients will be accrued to 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 |
|---|---|---|---|
| NCI-V98-1478 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066654 | REGISTRY | None | None |