Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478452
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2007-05-22
Brief Title:
Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Randomized Phase III Pilot Study of the Immunogenicity of Cyclophosphamide With Peptide Pulsed Mature Dendritic Cells for Patients With Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-10
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:
DC-Ova
Brief Summary:
This is a randomized Phase III study designed to assess the induction of an anti-tumor immune response the effect of cyclophosphamide on the vaccine and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine with or without a single dose of cyclophosphamide
Potential benefit may range from no direct benefit to the study participants to stimulation of the subjects own immune system to attack ovarian cancer to prevent relapse
Potential benefit may range from no direct benefit to the study participants to stimulation of the subjects own immune system to attack ovarian cancer to prevent relapse
Detailed Description:
HLA-A2 subjects with stage II-IV who have completed chemotherapy and are in clinical remission or patients with stage I-IV advanced ovarian cancer or primary serous peritoneal cancer in clinical remission post treatment for disease recurrence occurring after a progression-free interval of at least two years will be eligible Patients will be evaluated by standard imaging techniques Patients will be randomized to cyclophosphamide 300 mgm2 arm 2 or no cyclophosphamide arm 1 All subjects will receive intradermal injections of DC on day 2 and on week 3 6 and 9 3 days All subjects will undergo leukocyte apheresis at study enrollment and at week 10 which is the end of active study intervention All study arm 1 and 2 patients without prior vaccination with the current seasons vaccine will receive a single dose of trivalent killed influenza vaccine and a single dose of Prevnar pneumococcal vaccine on the day they receive their first intradermal injections of DC on day 2
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 |
|---|---|---|---|
| UPCC 01803 | OTHER | CTSRMC | None |