Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002733
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Patients With Metastatic Cancer
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
ALPHA INTERFERON TUMOR INFILTRATING LYMPHOCYTES AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining different types of biological therapies including interferon alfa interleukin-2 and tumor infiltrating lymphocytes may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of biological therapies including interferon alfa interleukin-2 and tumor infiltrating lymphocytes in treating patients with metastatic cancer
PURPOSE Phase II trial to study the effectiveness of biological therapies including interferon alfa interleukin-2 and tumor infiltrating lymphocytes in treating patients with metastatic cancer
Detailed Description:
OBJECTIVES I Determine the response rate and failure-free survival in patients with metastatic cancer preferably melanoma or renal cell treated with autologous tumor infiltrating lymphocytes TIL interferon alfa IFN-A and interleukin-2 IL-2 II Describe the toxic effects and costs associated with this therapy to assess risk benefit and cost benefit III Assess the relative value of administering low- or high-dose TIL as well as the value of administering IFN-A before TIL IL-2 with TIL or cimetidine with TIL
OUTLINE This is a multicenter study Patients are stratified according to center tumor infiltrating lymphocyte TIL dose low vs high and medical condition suitable for interferon alfa IFN-Ainterleukin-2 IL-2 yes vs no Patients are assigned to one of two treatment regimens based on entry criteria Regimen A preferred Patients meeting the preferred entry criteria receive IFN-A subcutaneously on days 1-4 TIL expanded in vitro with IL-2 IV on day 5 and IL-2 IV continuously over 72 hours following TIL infusion Regimen B All other patients receive TIL infusion once followed by oral cimetidine every 6 hours for 4 weeks Treatment repeats in both regimens every 3-6 weeks in the absence of disease progression and according to TIL availability Patients are followed every 6 months
PROJECTED ACCRUAL A total of 20-30 patients with melanoma and 20-30 patients with renal cell carcinoma will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to center tumor infiltrating lymphocyte TIL dose low vs high and medical condition suitable for interferon alfa IFN-Ainterleukin-2 IL-2 yes vs no Patients are assigned to one of two treatment regimens based on entry criteria Regimen A preferred Patients meeting the preferred entry criteria receive IFN-A subcutaneously on days 1-4 TIL expanded in vitro with IL-2 IV on day 5 and IL-2 IV continuously over 72 hours following TIL infusion Regimen B All other patients receive TIL infusion once followed by oral cimetidine every 6 hours for 4 weeks Treatment repeats in both regimens every 3-6 weeks in the absence of disease progression and according to TIL availability Patients are followed every 6 months
PROJECTED ACCRUAL A total of 20-30 patients with melanoma and 20-30 patients with renal cell carcinoma will be accrued for 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-V96-0835 | None | None | None |
| CBRG-9510 | None | None | None |
| NBSG-9510 | None | None | None |