Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT02277392
Status:
WITHDRAWN
Last Update Posted:
2018-09-27
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase-I, Dose Escalation Study of Recombinant Human Interleukin-18 (Sb-485232) Combined With Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Following Lymphodepletion for Adult Patients With Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
A Phase-I, Dose Escalation Study of Recombinant Human Interleukin-18 (Sb-485232) Combined With Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Following Lymphodepletion for Adult Patients With Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Status:
WITHDRAWN
Status Verified Date:
2018-07
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 is a phase-I, dose escalation study to assess the safety and biological activity of cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and recombinant human interleukin-18 (SB-485232, IL-18) treatment in adult patients with recurrent, Stage III or IV ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent induction vaccination with whole tumor vaccine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: