A Phase I Study of NY-ESO-1 Overlapping Peptides (OLP4) With or Without Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer (EOC), Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission
Cohort I (n=3) will receive NY-ESO-1 OLP4 by subcutaneous injection once every 3 weeks
(weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. At week 16 patients will return
for final toxicity and immunologic assessments. If 0/3 DLT's are seen in Cohort I, this arm
will be considered safe and accrual for this arm will stop. If 1/3 patients experience a
DLT (as defined in section 11), then 3 further patients will be accrued. If 1/6 experience
a DLT this arm will be considered safe. If >1/6 patients in this arm experience a DLT then
this arm will not be considered safe, and accrual for the study will stop. If this arm is
considered safe we will proceed to Cohort II. Cohort II (n=3 + 6) will receive NY-ESO-1 OLP
in combination with Montanide immune adjuvant by subcutaneous injections, once every 3 weeks
(weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. At week 16 patients will return
for final toxicity and immunologic assessments. If 0/3 initial patients experience a DLT we
will add 6 further patients to this arm at the same dose and schedule described above, for a
total of 9 patients. If 1/3 patients have a DLT, we will accrue 3 further patients at this
dose and schedule. If 1/6 have a DLT this arm will be considered safe, and 3 further
patients will be tested. Cohort III will begin accrual after 6 patients in cohort II have
received all 5 vaccinations with no more than one DLT observed (this criterion has already
been met in the study). Cohort III (n=3 + 6) will receive NY-ESO-1 OLP mixed with Poly-ICLC
immunoadjuvant emulsified in Montanide by subcutaneous injections, once every 3 weeks (weeks
1, 4, 7, 10, and 13) for a total of 5 vaccinations. At week 16, patients will return for
final toxicity and immunologic assessments. If 0/3 initial patients in Cohort III
experience a DLT, 6 more patients will added to this for a total of 9 evaluable patients.
If 1/3 initial patients have a DLT, then 3 more patients will be accrued in cohort III. If
1/6 patients have a DLT, then this arm will be considered safe, and 3 further patients will
be accrued. Patient's vital signs will be monitored for one hour following each vaccination,
The three cohorts will be accrued sequentially. Cohort I will be accrued directly. Cohort
II will begin accrual when at least one patient in cohort I has received all 5 vaccinations.
Cohort III will begin accrual after 6 patients in cohort II have received all 5 vaccinations
with no more than one DLT observed (this criterion has already been met in the study).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety of repeated vaccination with NY-ESO-1 overlapping peptides (4) (OLP4) with or without immunoadjuvants Montanide and Poly-ICLC.
16 weeks
Yes
Paul Sabbatini, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
LUD2006-001
NCT00616941
August 2008
June 2011
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |