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Sponsors and Collaborators: |
Ludwig Institute for Cancer Research Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00616941 |
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 |
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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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 26 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental |
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.
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II: Experimental |
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.
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III: Experimental |
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.
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values within the following limits:
Exclusion Criteria:
Contact: Paul Sabbatini, MD | 212 639-6423 | sabbatip@mskcc.org |
Contact: David Spriggs, MD | 212-639-2203 |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Paul Sabbatini, MD 212-639-6423 sabbatip@mskcc.org | |
Contact: David Spriggs, MD 212-639-2203 | |
Principal Investigator: Paul Sabbatini, MD | |
Principal Investigator: David Spriggs, MD | |
Sub-Investigator: Carol Aghajanian, MD | |
Sub-Investigator: Katherine Bell-McGuinn, MD | |
Sub-Investigator: Anne Chiang, MD | |
Sub-Investigator: Martee Hensley, MD, MSc | |
Sub-Investigator: Jason Konner, MD | |
Sub-Investigator: Catherine Magid Diefenbach, MD | |
Sub-Investigator: William Tew, MD |
Principal Investigator: | Paul Sabbatini, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Ludwig Institute for Cancer Research ( Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs ) |
Study ID Numbers: | LUD2006-001, MSKCC IRB# 07-152 |
Study First Received: | February 4, 2008 |
Last Updated: | June 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00616941 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NY-ESO-1 OLP4 Ovarian Cancer Cancer Vaccine |
Fallopian Tube Cancer Ovarian Neoplasms Digestive System Neoplasms Immunologic Factors Gonadal Disorders Interferons Poly ICLC Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian Epithelial Cancer Abdominal Neoplasms Fallopian Tube Neoplasms Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Interferon Inducers Digestive System Neoplasms Ovarian Neoplasms Immunologic Factors Gonadal Disorders Physiological Effects of Drugs Poly ICLC Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Abdominal Neoplasms Pharmacologic Actions Fallopian Tube Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |