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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

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Trial Information

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).


Inclusion Criteria:



- Patients must have histologically documented epithelial carcinoma arising in the
ovary, fallopian tube, or peritoneum, from stage II-IV at diagnosis, receiving
initial cytoreductive surgery and chemotherapy with at least one platinum based
chemotherapy regimen.

- Patients must be in second or third complete clinical remission. Stable complete
clinical remission is defined as a) Stable CA125 < 35U/ml, (defined as CA125 that has
not doubled from the post chemotherapy nadir, b) unremarkable physical examination,
and c) no definite evidence of disease by computed tomography (CT) of the abdomen
and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often
present in the pelvis, may not be considered definite evidence of disease.

- Expected survival of at least 4 months.

- Karnofsky performance scale ≥70%.

- Laboratory values within the following limits:

- Hemoglobin > 10.0 g/dL

- Neutrophil count > 1.5 x l09/L

- Platelet count > 80 x l09/L

- Serum creatinine < 2.0 mg/dL

- Serum bilirubin < 2.5 x upper limit of institutional normal

- AST/ALT < 2.5 x upper limit of institutional normal

- Age ≥ 18 years.

- Patient is > 4 weeks from completion of prior cytotoxic chemotherapy.

- Able and willing to give valid written informed consent

Exclusion Criteria:

- Clinically significant heart disease (NYHA Class III or IV).

- Patients with serious intercurrent illness, e.g., serious infections requiring
prolonged parenteral antibiotics or bleeding disorders requiring hospitalization.

- Patients with a positive stool guaiac excluding hemorrhoids.

- Patients with known autoimmune disease (ie rheumatoid arthritis, ulcerative colitis
etc); or immune deficiency (HIV, hypogammaglobulinemia); or known active infections
with Hepatitis B or Hepatitis C; or those receiving immunosuppressive drugs such as
systemic corticosteroids or cyclosporin, etc).

- Other malignancy within 3 years prior to entry into the study, except for treated
non-melanoma skin cancer and cervical carcinoma in situ.

- History of previous severe allergic reactions to vaccines or unknown allergens.

- Mental impairment that may compromise the ability to give informed consent and comply
with the requirements of the study.

- Lack of availability for immunological and clinical follow-up assessments.

- Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to first dose of study agent.

- Pregnancy or breast-feeding.

- Women of childbearing potential: Refusal or inability to use effective means of
contraception.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of repeated vaccination with NY-ESO-1 overlapping peptides (4) (OLP4) with or without immunoadjuvants Montanide and Poly-ICLC.

Outcome Time Frame:

16 weeks

Safety Issue:

Yes

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

LUD2006-001

NCT ID:

NCT00616941

Start Date:

August 2008

Completion Date:

June 2011

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • NY-ESO-1 OLP4
  • Ovarian Cancer
  • Cancer Vaccine
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021