Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004248
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2000-01-28
Brief Title:
Doxorubicin and Interleukin-2 in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Low Dose Schedule of Adriamycin and Protracted Infusion of Recombinant Interleukin-2 A Phase II Study of Immunotherapy in Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-03
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 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 liver cancer cells
PURPOSE Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in treating patients who have liver cancer that cannot be removed by surgery
PURPOSE Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in treating patients who have liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES I Evaluate the immunological response to doxorubicin and protracted recombinant interleukin-2 in terms of alterations in hepatocellular carcinoma specific cytotoxic T cells detectable in peripheral blood in patients with unresectable hepatocellular carcinoma II Determine the toxicity of this treatment regimen in this patient population III Determine the tumor response to this regimen in terms of changes in alpha fetoprotein and tumor size measured by CT scan in these patients IV Determine the progression free survival and overall survival of this patient population treated with this regimen V Determine the correlation between immunological response tumor response progression free survival and overall survival in these patients
OUTLINE Patients receive doxorubicin IV over 3-5 minutes on day 1 and recombinant interleukin-2 IL-2 IV continuously beginning on day 5 and continuing until day 57 Patients achieving partial or complete clinical response regardless of immunological response and patients with stable disease and an immunological response continue on IL-2 therapy continuously until day 92 Patients with stable disease and no immunological response receive an additional dose of doxorubicin on day 57 and then continue on IL-2 until day 92 Patients who are clinically eligible with progressive disease and an immunological response continue IL-2 therapy as above Patients are followed at 2 weeks and then monthly thereafter
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within approximately 3 years
OUTLINE Patients receive doxorubicin IV over 3-5 minutes on day 1 and recombinant interleukin-2 IL-2 IV continuously beginning on day 5 and continuing until day 57 Patients achieving partial or complete clinical response regardless of immunological response and patients with stable disease and an immunological response continue on IL-2 therapy continuously until day 92 Patients with stable disease and no immunological response receive an additional dose of doxorubicin on day 57 and then continue on IL-2 until day 92 Patients who are clinically eligible with progressive disease and an immunological response continue IL-2 therapy as above Patients are followed at 2 weeks and then monthly thereafter
PROJECTED ACCRUAL A total of 24-30 patients will be accrued for this study within approximately 3 years
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 |
|---|---|---|---|
| RPCI-RP-9814 | None | None | None |