Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002475
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
Sponsor:
St Vincent Medical Center - Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
Status:
COMPLETED
Status Verified Date:
2008-11
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 work in different ways to stop tumor cells from dividing so they stop growing or die Vaccines made from a patients tumor tissue may make the body build an immune response to kill tumor cells Chemotherapy combined with vaccine therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining cyclophosphamide with tumor cell vaccine in treating patients who have metastatic cancer or cancer at high risk of recurrence
PURPOSE Phase II trial to study the effectiveness of combining cyclophosphamide with tumor cell vaccine in treating patients who have metastatic cancer or cancer at high risk of recurrence
Detailed Description:
OBJECTIVES
Determine the safety and clinical effects of autologous or allogeneic active-specific intralymphatic immunotherapy with a vaccine containing interferon alfa or interferon gamma-treated tumor cells followed by sargramostim GM-CSF in patients with advanced cancer
OUTLINE This is a pilot study Patients are stratified by tumor type
Tumor tissue is removed from the patient and incubated with interferon alfa or interferon gamma for 72-96 hours If autologous tumor cells are not available an allogeneic vaccine is prepared Harvested activated cells are irradiated immediately prior to use
Patients receive cyclophosphamide IV 48-72 hours after cyclophosphamide administration patients receive tumor cell vaccine intradermally Patients also receive sargramostim GM-CSF subcutaneously prior to vaccine administration and once daily for the next 8 days Treatment repeats every 2 weeks for 3 courses in the absence of unacceptable toxicity Patients with responding or stable disease after completion of course 3 may receive additional courses
Patients are followed for survival
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 18-24 months
Determine the safety and clinical effects of autologous or allogeneic active-specific intralymphatic immunotherapy with a vaccine containing interferon alfa or interferon gamma-treated tumor cells followed by sargramostim GM-CSF in patients with advanced cancer
OUTLINE This is a pilot study Patients are stratified by tumor type
Tumor tissue is removed from the patient and incubated with interferon alfa or interferon gamma for 72-96 hours If autologous tumor cells are not available an allogeneic vaccine is prepared Harvested activated cells are irradiated immediately prior to use
Patients receive cyclophosphamide IV 48-72 hours after cyclophosphamide administration patients receive tumor cell vaccine intradermally Patients also receive sargramostim GM-CSF subcutaneously prior to vaccine administration and once daily for the next 8 days Treatment repeats every 2 weeks for 3 courses in the absence of unacceptable toxicity Patients with responding or stable disease after completion of course 3 may receive additional courses
Patients are followed for survival
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 18-24 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V91-0075 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000076913 | REGISTRY | None | None |