Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002773
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Vaccine Therapy Chemotherapy and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
St Vincent Medical Center - Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS GMCSF AND LOW-DOSE CYCLOPHOSPHAMIDE
Status:
COMPLETED
Status Verified Date:
2007-04
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 Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Colony-stimulating factors may help a persons immune system recover from the side effects of chemotherapy Combining these treatments may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer
Detailed Description:
OBJECTIVES I Determine the feasibility toxicity and antitumor effects of active specific intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon alfa plus low-dose adjuvant systemic sargramostim GM-CSF and cyclophosphamide in patients with incurable pancreatic adenocarcinoma II Assess the immunologic and biologic correlates of this treatment regimen in these patients
OUTLINE Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours Autologous cell lines if established may be used as an alternative The cells are irradiated immediately prior to use Patients receive cyclophosphamide IV on day -3 and sargramostim GM-CSF subcutaneously on days 0-8 On day 0 patients receive viable tumor cells via dorsal pedal lymphatic cannulation Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 2-4 months
PROJECTED ACCRUAL A total of 14 patients will be accrued for this study
OUTLINE Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours Autologous cell lines if established may be used as an alternative The cells are irradiated immediately prior to use Patients receive cyclophosphamide IV on day -3 and sargramostim GM-CSF subcutaneously on days 0-8 On day 0 patients receive viable tumor cells via dorsal pedal lymphatic cannulation Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 2-4 months
PROJECTED ACCRUAL A total of 14 patients 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-V96-0886 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064749 | REGISTRY | None | None |