Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003656
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
1999-11-01
Brief Title:
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-03
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 Tretinoin may help kidney cancer cells develop into normal cells Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b
Determine the toxicity of this regimen in these patients
Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies
OUTLINE This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b Phase I closed to accrual as of 92403
Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days M-F for 8 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose MTD has been determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued and treated at that dose Phase I closed to accrual as of 92403
During the first 3 weeks of the study patients receive interferon alfa-2b at weekly dose escalations After week 3 patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study Phase I closed to accrual as of 92403
Patients are followed at 30 days after the last treatment
PROJECTED ACCRUAL A total of 3-18 patients will be accrued into the phase I portion of this study Phase I closed to accrual as of 92403 A total of 14-25 patients will be accrued into the phase II portion of this study
Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b
Determine the toxicity of this regimen in these patients
Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies
OUTLINE This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b Phase I closed to accrual as of 92403
Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days M-F for 8 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose MTD has been determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued and treated at that dose Phase I closed to accrual as of 92403
During the first 3 weeks of the study patients receive interferon alfa-2b at weekly dose escalations After week 3 patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study Phase I closed to accrual as of 92403
Patients are followed at 30 days after the last treatment
PROJECTED ACCRUAL A total of 3-18 patients will be accrued into the phase I portion of this study Phase I closed to accrual as of 92403 A total of 14-25 patients will be accrued into the phase II portion of 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-V98-1490 | None | None | None |
| NYWCCC-0498-209 | None | None | None |