Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518206
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2007-08-16
Brief Title:
Study of NY-ESO-1 ISCOMATRIX in Patients With Measurable Stage III or IV Melanoma
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Phase II Study of the Clinical and Immunological Effects of NY-ESO-1 ISCOM Vaccine in Patients With Measurable Stage III and IV Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2022-10
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 open-label study of the NY-ESO-1 ISCOMATRIX ISCOM vaccine administered as an intramuscular injection given every 4 weeks to subjects with measurable advanced malignant melanoma Study objectives included determination of the anticancer activity cellular and humoral immunogenicity and safety and tolerability of the NY-ESO-1 ISCOM vaccine administered alone or preceded by a single administration of low-dose cyclophosphamide
Detailed Description:
In Cohort 1 6 subjects were initially vaccinated with the NY-ESO-1 ISCOM vaccine at a dose of 100 µg of the NY-ESO-1 protein 120 µg of the ISCOM adjuvant These 6 subjects were monitored for dose-limiting toxicity DLT for 7 days after the first vaccination Upon observation of tolerability ie 26 subjects with DLT enrollment proceeded to a total accrual of approximately 25 subjects Subjects received 3 vaccinations administered every 4 weeks ie weeks 1 5 and 9 followed by immunological and clinical response evaluations with clinical responses categorized according to the Response Evaluation Criteria in Solid Tumors RECIST In the absence of disease progression subjects may have received 3 additional vaccinations administered every 4 weeks followed by additional vaccinations administered every 12 weeks thereafter until development of disease progression or other criteria for discontinuation
In Cohort 2 subjects received the NY-ESO-1 ISCOM vaccine on the same schedule as described for Cohort 1 but Cohort 2 subjects also received a single intravenous infusion of low-dose cyclophosphamide 1 day prior to each NY-ESO-1 ISCOM vaccination If responses were observed in 2 of 16 subjects initially treated in Cohort 2 then 9 additional subjects were to be accrued to Cohort 2 for a total potential accrual of 25 subjects
In Cohort 2 subjects received the NY-ESO-1 ISCOM vaccine on the same schedule as described for Cohort 1 but Cohort 2 subjects also received a single intravenous infusion of low-dose cyclophosphamide 1 day prior to each NY-ESO-1 ISCOM vaccination If responses were observed in 2 of 16 subjects initially treated in Cohort 2 then 9 additional subjects were to be accrued to Cohort 2 for a total potential accrual of 25 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CTN-Protocol LUD2002-013AMEND | None | None | None |
| CTN Trial No 2007123 | None | None | None |