Ignite Creation Date:
2024-05-06 @ 2:53 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02151448
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2014-05-28
Brief Title:
αDC1 Vaccine Chemokine Modulatory Regimen CKM as Adjuvant Treatment of Peritoneal Surface Malignancies
Sponsor:
David Bartlett
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase 12 Trial Evaluating αDC1 Vaccines Combined With Tumor-Selective Chemokine Modulation as Adjuvant Therapy After Surgical Resection of Peritoneal Surface Malignancies
Status:
COMPLETED
Status Verified Date:
2020-07
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:
This trial is to determine the safest dose of a triple combination chemokine modulatory regimen or CKM of celecoxib interferon alfa IFN and rintatolimod that can be given with a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery
The first phase of this study will determine the safest dose of IFN that can be given in combination with celecoxib and rintatolimod along with a DC vaccine The doses of celecoxib 400 mg and rintatolimod 200 mg will be consistent while the dose of IFN will be increased 5 10 or 20 MUm2 as participants are enrolled to the trial The high dose of IFN in combination with celecoxib and rintatolimod will be used for the next phase of the clinical trial After surgery participants will receive 2 cycles of the investigational treatment
The second phase of this study will test if the investigational treatment has any effects on peritoneal surface malignancies The doses of the combination determined in the first phase will be used in this phase of the clinical trial After surgery participants will receive 2 cycles of the investigational treatment followed by standard chemotherapy as determined by their oncologist and then 2 more cycles of the investigational treatment
The first phase of this study will determine the safest dose of IFN that can be given in combination with celecoxib and rintatolimod along with a DC vaccine The doses of celecoxib 400 mg and rintatolimod 200 mg will be consistent while the dose of IFN will be increased 5 10 or 20 MUm2 as participants are enrolled to the trial The high dose of IFN in combination with celecoxib and rintatolimod will be used for the next phase of the clinical trial After surgery participants will receive 2 cycles of the investigational treatment
The second phase of this study will test if the investigational treatment has any effects on peritoneal surface malignancies The doses of the combination determined in the first phase will be used in this phase of the clinical trial After surgery participants will receive 2 cycles of the investigational treatment followed by standard chemotherapy as determined by their oncologist and then 2 more cycles of the investigational treatment
Detailed Description:
This trial will evaluate the safety and effectiveness of autologous alpha-type-1 polarized dendritic cell alpha-DC1 vaccines patients autologous alpha-DC1s loaded with autologous tumor material combined with a systemic chemokine modulation regimen CKM intravenous rintatolimod TLR3 ligand a derivative of Poly-IC intravenous interferon-alfa oral celecoxib as adjuvant therapy after cytoreductive surgery CRS and hyperthermic intraperitoneal chemotherapy HIPEC in patients with peritoneal surface malignancies PSM including but not limited to malignant peritoneal mesothelioma and peritoneal carcinomatosis PC of appendiceal and colorectal origin
All patients judged to have peritoneal surface malignancy and considered able to be cytoreduced to Peritoneal Cancer Index PCI Completeness of Cytoreduction CC score of 1 or less will undergo CRS HIPEC Postoperative immunotherapy will start at least 4 weeks after CRS HIPEC
Immunotherapy regimen will include four cycles of intranodal 3M cells and intradermal 3M cells αDC1 vaccines Each booster αDC1 vaccine dose treatment cycles 2-4 will be followed by 4-days of systemic CKM starting the day after vaccination IFNα dose-escalation 5-20 MUm2 intravenous IV once a day for 4 days rintatolimod short-half-life TLR3 ligand 200 mg intravenous IV on Wednesday and Friday only of the CKM regimen and celecoxib 200 mg orally twice a day for 4 days In order to avoid overlap between experimental immunotherapy and potential adjuvant chemotherapy which can be clinically indicated as a part of standard care in the subset of patients the experimental treatments will be interrupted after cycles 1 and 2 to allow adjuvant chemotherapy that is done for each patients clinical care and is not a part of this research study Whenever clinically indicated as a part of standard care adjuvant chemotherapy may start at least 5 days after completion of the 2nd cycle of immunotherapy first booster vaccine plus the first CKM The 3rd cycle of immunotherapy may start at least 5 days after the completion of chemotherapy
All patients judged to have peritoneal surface malignancy and considered able to be cytoreduced to Peritoneal Cancer Index PCI Completeness of Cytoreduction CC score of 1 or less will undergo CRS HIPEC Postoperative immunotherapy will start at least 4 weeks after CRS HIPEC
Immunotherapy regimen will include four cycles of intranodal 3M cells and intradermal 3M cells αDC1 vaccines Each booster αDC1 vaccine dose treatment cycles 2-4 will be followed by 4-days of systemic CKM starting the day after vaccination IFNα dose-escalation 5-20 MUm2 intravenous IV once a day for 4 days rintatolimod short-half-life TLR3 ligand 200 mg intravenous IV on Wednesday and Friday only of the CKM regimen and celecoxib 200 mg orally twice a day for 4 days In order to avoid overlap between experimental immunotherapy and potential adjuvant chemotherapy which can be clinically indicated as a part of standard care in the subset of patients the experimental treatments will be interrupted after cycles 1 and 2 to allow adjuvant chemotherapy that is done for each patients clinical care and is not a part of this research study Whenever clinically indicated as a part of standard care adjuvant chemotherapy may start at least 5 days after completion of the 2nd cycle of immunotherapy first booster vaccine plus the first CKM The 3rd cycle of immunotherapy may start at least 5 days after the completion of chemotherapy
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 |
|---|---|---|---|
| 5P01CA132714-05 | NIH | None | None |
| 12-110 | OTHER | University of Pittsburgh Cancer Institute | httpsreporternihgovquickSearch5P01CA132714-05 |