Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003974
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Stage I Stage II or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
An Evaluation of the Immunological Parameters Associated With a Skin-Test and Immunization of Lung and Mesothelioma Cancer Patients With Autologous Lung Tumor Associated Antigen Characterization of the Patients Cytolytic and Helper T Cell Reactivity for Identification of the Specific Antigens A Pilot Study
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 Vaccines made from a persons tumor may help the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have undergone surgery to remove stage I stage II or stage IIIA non-small cell lung cancer or stage I or stage II mesothelioma
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have undergone surgery to remove stage I stage II or stage IIIA non-small cell lung cancer or stage I or stage II mesothelioma
Detailed Description:
OBJECTIVES I Define the immunological parameters of cytolytic T cell and T helper cell activity associated with skin testing and vaccination with autologous lung tumor associated antigen and detoxPC in patients with curatively resected stage I II or IIIA non-small cell lung cancer NSCLC or stage I or II mesothelioma II Evaluate any responses associated with an enhanced antitumor immune status in this patient population with this treatment regimen
OUTLINE Patients undergo delayed type hypersensitivity skin testing with autologous tumor associated antigen TAA and memory antigens ie Monilia PPD and Trichophyton intradermally at 1-4 weeks following surgical tumor resection At week 4-9 patients receive low dose cyclophosphamide IV once At 3 days following chemotherapy patients receive autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks At 2-3 weeks following vaccination patients undergo repeat skin testing At week 6-12 patients with a positive skin test undergo biopsy of the skin testvaccination site followed by leukapheresis at week 12-20 if T cells exhibit active antitumor reactivity Patients with stable or regressive disease receive additional vaccination courses at week 20 and thereafter Patients are followed for 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 2 years
OUTLINE Patients undergo delayed type hypersensitivity skin testing with autologous tumor associated antigen TAA and memory antigens ie Monilia PPD and Trichophyton intradermally at 1-4 weeks following surgical tumor resection At week 4-9 patients receive low dose cyclophosphamide IV once At 3 days following chemotherapy patients receive autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks At 2-3 weeks following vaccination patients undergo repeat skin testing At week 6-12 patients with a positive skin test undergo biopsy of the skin testvaccination site followed by leukapheresis at week 12-20 if T cells exhibit active antitumor reactivity Patients with stable or regressive disease receive additional vaccination courses at week 20 and thereafter Patients are followed for 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 2 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-DS-96-25 | None | None | None |