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A Phase I Study of NY-ESO-1 Overlapping Peptides (OLP4) Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer (EOC), Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission

This study has been completed.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00616941
First received: February 4, 2008
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

This is an open label, Phase I study of vaccination with NY-ESO-1 OLP4 with or without immunoadjuvant Montanide and Poly-ICLC in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in second or third clinical remission.

The primary and secondary endpoints of the study are to determine the safety and immunogenicity of NY-ESO-1 OLP4 vaccination with or without immunoadjuvants Montanide and Poly-ICLC.


Condition Intervention Phase
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Biological: NY-ESO-1 OLP4
Biological: NY-ESO-1 OLP4 + Montanide
Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • To assess the safety of repeated vaccination with NY-ESO-1 overlapping peptides (4) (OLP4) with or without immunoadjuvants Montanide and Poly-ICLC. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the immune response (NY-ESO-1 antibody, CD4+ and CD8+ cells) induced by NY-ESO-1 OLP4 vaccine with or without immunoadjuvants Montanide and Poly-ICLC. [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Biological: NY-ESO-1 OLP4
1 mg of NY-ESO-1 OLP4 will be diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.
Experimental: II Biological: NY-ESO-1 OLP4 + Montanide
1 mg of NY-ESO-1 OLP4 will be diluted in 0.5 mL of D5W, mixed with 0.5mL of Montanide and administered subcutaneously as a single injection.
Experimental: III Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC
1 mg NY-ESO-1 OLP4 + 1.4 mg Poly-ICLC emulsified in 1 mL Montanide and administered subcutaneously as two injections.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616941

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs, Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00616941     History of Changes
Other Study ID Numbers: LUD2006-001, MSKCC IRB# 07-152
Study First Received: February 4, 2008
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
NY-ESO-1 OLP4
Ovarian Cancer
Cancer Vaccine

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Adjuvants, Immunologic
Poly ICLC
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014