Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112957
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2005-06-02
Brief Title:
Vaccine Therapy in Patients With Stage II III or IV Epithelial Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase II Study of Recombinant Vaccinia-NY-ESO-1 rV-NY-ESO-1 and Recombinant Fowlpox-NY-ESO-1 rF-NY-ESO-1 in Patients With Epithelial Ovarian Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
Brief Summary:
This was a Phase 2 single-center open-label study of recombinant vaccinia-NY-ESO-1 rV-NY-ESO-1 and recombinant fowlpox-NY-ESO-1 rF-NY-ESO-1 injections in patients who had a complete response to standard therapy for epithelial ovarian fallopian tube or primary peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen Study objectives were to evaluate maintenance of remission at 12 months time to failure of vaccine therapy cellular and humoral immunity and any correlation with time to failure and safety
Detailed Description:
Patients received a single intradermal injection of rV-NY-ESO-1 31 107 plaque forming units PFU on Day 1 followed by monthly subcutaneous injections of rF-NY-ESO-1 741 107 PFU for 6 months Days 29 57 85 113 141 and 169 or until observation of treatment-related grade 3 toxicity or disease progression Study injections were administered during a 28-week evaluation period Patients returned to the clinic for follow-up on Day 197 ie 28 days after the last study injection and every 2 months thereafter for at least 12 months In patients with measurable disease tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors RECIST version 10 Patients were monitored continuously for safety for the duration of study participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000424461 | None | None | None |
| RPCI-I-13303 | None | None | None |