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Sponsors and Collaborators: |
Duke University Immunotope |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00437502 |
This study will evaluate the safety of administering a peptide vaccine consisting of twelve different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.
Condition | Intervention | Phase |
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Epithelial Ovarian, Tubal or Peritoneal Cancer |
Biological: OCPM Immunotherapeutic Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal, or Peritoneal Cancer |
The primary endpoint will be to determine the safety and feasibility of administering ovarian cancer peptides to women who have undergone debulking surgery and systemic chemotherapy, with the secondary objectives of evaluating immune response as measured by ELISPOT to the immunizations, to compare the immune response as measured by ELISPOT achieved by the two different dosing strategies and to assess disease relapse survival. Two cohorts of 9 patients each will be treated with different doses of the OCPM vaccine. They will receive the peptide vaccine subcutaneously on weeks 0,1,2,3,5 and6 and then receive the immunizations every 1 month for 6 months or disease recurrence. The first 9 patients will be entered into the first cohort; if 1 or fewer patients experience Dose-limiting toxicity (DLT) then the next 9 will be enrolled into the second cohort. DLT is defined as any Grade 3 or greater hematologic or non-hematologic toxicity or autoimmune disease (except for fever, skin reaction, or alopecia which would be grade 4) occurring at any time from the first immunization until 30 days after the last immunization. Toxicity will be assessed at each dose level using CTC toxicity criteria. Ovarian cancer peptide-specific immune response will be measured by ELISpot. Time to disease relapse will be based on composite assessment of clinical signs, objective exam findings, radiologic imaging, and CA125 results. A dosing scheme will be considered safe if <1 of the first 9 subjects treated at a dose level experience DLT (as described above). A subject will be considered evaluable for safety if treated with at least one immunization. A T cell response will be considered positive by ELISpot if: the mean number of spots in six wells with antigen exceeds the number of spots in six control wells by 10 and the difference between single values of the six wells containing antigen and the six control wells is statistically significant at a level of p ≤ 0.05 using Student's t test.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must be HLA-A2+ patients with histologically confirmed, stage III-IV epithelial ovarian, tubal, or peritoneal cancer who have undergone optimal debulking and had a complete clinical response to front-line platin/taxane based chemotherapy.
Exclusion Criteria:
Contact: Nancy J Lee, RN | 919-681-5595 | Nancy.Lee@duke.edu |
Contact: Liz Anderson, RN | 919-668-5591or 6406 | ander094@mc.duke.edu |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Nancy Lee, RN 919-681-5595 Nancy.Lee@duke.edu | |
Contact: Liz Anderson, RN 919-668-5591or 6406 ander094@mc.duke.edu | |
Principal Investigator: Michael Morse, MD | |
Sub-Investigator: Angeles Secord, MD |
Principal Investigator: | Michael Morse, MD | Duke University |
Principal Investigator: | Angeles A Secord, MD | Duke University |
Principal Investigator: | Ramila Philip, PhD | Immunotope |
Study ID Numbers: | BB-IND 12605 |
Study First Received: | February 19, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00437502 |
Health Authority: | United States: Food and Drug Administration |
Immunotherapeutic vaccine Ovarian cancer epithelial ovarian cancer |
tubal cancer peritoneal cancer immunotherapy |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Abdominal Neoplasms Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |